Angina Equivalent, Chest Pain, Coronary Artery Disease, Stable Angina Pectoris, CCS Class I to III
Conditions
Keywords
stable angina, recurrent chest pain, chest pain, angina equivalent, diagnosis, coronary artery disease
Brief summary
This randomized, controlled, diagnostic, multicenter trial will compare two diagnostic imaging pathways--coronary computed tomography angiography (CCTA) and single photon emission tomography (SPECT) myocardial perfusion imaging (MPI)--to determine the incidence of major adverse coronary events (MACE), defined as myocardial infarction (MI) or cardiac-related death, and cross-over to revascularization. CCTA may be used to direct patients with symptoms of stable angina or angina equivalent to optimal medical therapy (OMT). The use of CCTA as a diagnostic tool for angina symptoms will be associated with no increase in MACE or revascularization, decreased cost, reduced risks (e.g., less radiation exposure), additional insights into alternate explanations of chest pain, and increased cost-effectiveness in comparison with use of SPECT MPI/invasive coronary angiography (ICA).
Detailed description
The Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Diagnostic Examinations (RESCUE) is a multi-center randomized, controlled trial responding to the need for comparative analysis of these imaging technologies and the role of OMT in clinical care. A total of 4300 patients will be randomized to CCTA or SPECT MPI/ICA for diagnostic assessment of angina at up to 80 institutions internationally. This study builds on the results of the COURAGE trial by comparing CCTA and SPECT MPI/ICA integrated into a care paradigm featuring initial treatment with OMT for patients diagnosed using computer-aided diagnosis (CAD) without significant disease in the left main coronary artery. Participants will be followed for a composite endpoint of MACE and cross-over to revascularization over a follow-up period up to two years (two to six time points depending on diagnostic results and time of enrollment into the trial). The primary endpoint of the study is a combined endpoint of occurrence of MACE and revascularization. We will calculate differences in the combined MACE/revascularization endpoint between the CCTA and SPECT MPI/ICA arms. Participant outcomes will be assessed by age, gender, comorbidity, and angina classification class at presentation. Several comparative-effectiveness analyses will be performed. We hypothesize that the CCTA arm will be associated with no increase in MACE or revascularization, decreased cost, reduced risks (e.g., less radiation exposure), additional insights into or alternate explanations of chest pain, and increased cost-effectiveness in comparison with SPECT MPI/ICA. Findings are expected to result in validation of an evolving new standard of care for patients with stable angina that takes advantage of CCTA and OMT to more cost-effectively drive appropriate care while reducing the need for invasive diagnosis and increased radiation exposure with SPECT MPI/ICA.
Interventions
DEVICECCTA
Complete diagnostic CCTA per protocol specifications.
DEVICESPECT MPI/ICA
Perform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol.
Sponsors
American College of Radiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This randomized, controlled, diagnostic, multicenter trial will follow participants at 6-month intervals for up to 24 months to determine the incidence of MACE, defined as myocardial infarction (MI) or cardiac-related death, and cross-over to revascularization.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to provide a written informed consent; * 40 years or older; * Presentation with symptoms of stable angina (CCS Class I to III) or angina equivalent with or without known CAD; * Planned non-invasive imaging for CAD diagnosis; * Able to tolerate CCTA or SPECT MPI per randomization as required by protocol, to be performed at an ACRIN-qualified facility with a RESCUE-qualified scanner.
Exclusion criteria
* Prior revascularization; * Not suitable to undergo CT with an iodinated contrast agent: * Known allergy-like reaction to contrast media as defined by the American College of Radiology (ACR) (see www.acr.org/SecondaryMainMenuCategories/quality\_safety/contrast\_manual.aspx for reaction definition) or moderate to severe allergic reactions to more than one allergen; * Renal failure, as determined by glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2 based on a serum creatinine level obtained within 28 days prior to registration; * Renal insufficiency at the time of enrollment, as determined by GFR 30 to 60 mL/min/1.73 m2 based on a serum creatinine level obtained within 28 days prior to registration, unless permitted by the institution's policy and/or ACR guidance for risk reduction strategies (see www.acr.org/SecondaryMainMenuCategories/quality\_safety/contrast\_manual.aspx for guidance on contrast selection and pre-treatment strategies); * Atrial fibrillation or significant arrhythmia judged to potentially limit quality of CCTA; * Acute ischemia; * Acute myocardial infarction; * Severe myocardial ischemia: known markedly positive exercise treadmill stress test (ST) \[significant ST segment depressions or hypotensive response during stage I of the Bruce protocol\]; * Unable to suspend respiration for 15 seconds or to follow instructions to do so; * Unstable angina and symptoms refractory to maximal oral and intravenous medical therapy (persistent CCS Class IV); * History of known left ventricular ejection fraction \< 45%; * Pulmonary edema or heart failure unresponsive to standard medical therapy; * Pacemaker; * Valvular heart disease likely to require surgery in the next 18 months; * Congenital heart disease or cardiomyopathy likely to affect prognosis during follow up; * Significant systemic hypertension (blood pressure \> 200/100 mm Hg) unresponsive to medical therapy; * Severe noncardiovascular comorbidity limiting survival (e.g., cancer or other life threatening illness for which the patient is expected to live less than 12 months); * Prior imaging evaluation for this episode of symptoms (e.g., SPECT MPI or CCTA within the previous 72 hours); * BMI \> 40 kg/m2; * Pregnancy or intent to become pregnant (if a female is of childbearing potential-defined as a premenopausal female capable of becoming pregnant-a pregnancy test should be done prior to enrollment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-dependent Rates of the Composite Primary Endpoint Major Adverse Cardiovascular Event (MACE: Comprising Cardiac-related Death or Acute Myocardial Infarction (AMI), and Revascularization) | up to 24 Months (depends on time of trial enrollment and funding duration) | To compare outcomes of participants with symptoms of stable angina or angina equivalent evaluated with an anatomic imaging strategy using CCTA as initial method of computer-aided diagnosis (CAD) (Group A) to a combined functional and anatomic imaging strategy of SPECT MPI/ICA (Group B) as a guide to Optimal Medical Therapy (OMT) alone. The analysis was conducted from an intent-to-treat perspective |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prediction of Response (MACE/Revascularization) at 1 Year Using: Modified Duke Score or CCTA + AHA 16 Predictor/CCTA+AHA 16+Clinical Data Predictor or SPECT% Reversible Defect Size Reported as Receiver Operating Characteristic (ROC) Area Under Curve (AUC) | 1 year | AUC is a unitless measure of performance ranging form 0.5 (guessing) to 1.0 (perfect predictor) that can be thought of a the proportion of correct classifications in a 2-alternative-forced-choice experiment - and for binary outcomes, it is equivalent to the C-statistic. It will be used to evaluate and compare the ability of available prognostic indices and SPECT-MPI % reversible defect size to predict revascularization or MACE using CCTA information: A CCTA Modified Duke index A CCTA index including the 16 individual American Heart Association (AHA) segments A CCTA including the 16 individual AHA segments and clinical data and compare them to the SPECT % reversible defect size results |
| Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | baseline and 12 months | SF36+SAQ at baseline and to a subset of participants, stratified by diagnostic examination, at 12 months after enrollment to monitor angina symptoms and their impact on Quality of life. The Short Form-36 (SF36) is a 36 item overall health status/Quality of Life collected in 8 domains. Scales are standardized with scores ranging from 0-100. Higher scores= better health status. The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item, cardiac disease-related quality-of-life measure collected in 5 domains. scales are standardized with scores ranging from 0-100. Higher scores= better health status. Positive cardiac findings on diagnostic testing are defined as: 1. 50% stenosis on CCTA or un-evaluable left main, or proximal and mid segments of all other epicardial arteries (right coronary artery, left anterior descending artery, or left circumflex artery); and 2. 10% reversible defect on SPECT MPI or evidence of Transient Ischemic Dilation (TID) accompanied by ECG |
| The Effectiveness of Each Arm Will be Measured in Terms of Life Years and Quality of Life Years (QALY). | Baseline and 1 year | International medical records will be used to determine mortality which may not be feasible at all participating international sites. Utilities will be based on Quality of Well Being scores converted from the SF-36 assessments The analysis will be performed assuming a societal perspective and lifetime time horizon |
Countries
United States
Participant flow
Recruitment details
The study opened to enrollment in May 2011 and was closed to enrollment in June 2013 due to resource limitations. The study was designed to enroll and randomize 4300 participants to the 2 study arms, but given the difficulties of recruiting enough patients to fulfill the stringent entry criteria, as well as time constraints for funding (American Recovery and Reinvestment Act award, 3-year cap), only one quarter of the planned sample size could be recruited .
Participants by arm
| Arm | Count |
|---|---|
| Group A: CCTA Diagnostic Participants randomized to diagnostic evaluation using CCTA to determine therapeutic course of action.
CCTA: Complete diagnostic CCTA per protocol specifications. | 516 |
| Group B: SPECT MPI/ICA Diagnostic Standard-of-care diagnostic assessment using SPECT MPI, possibly followed by diagnostic ICA dependent on SPECT MPI results.
SPECT MPI/ICA: Perform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol. | 531 |
| Total | 1,047 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Error | 1 | 1 |
| Overall Study | Site Closed | 1 | 0 |
Baseline characteristics
| Characteristic | Group B: SPECT MPI/ICA Diagnostic | Total | Group A: CCTA Diagnostic |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 9 | 58 years STANDARD_DEVIATION 9 | 57 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 58 Participants | 104 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 468 Participants | 935 Participants | 467 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 15 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 25 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 77 Participants | 150 Participants | 73 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 15 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 24 Participants | 12 Participants |
| Race (NIH/OMB) White | 415 Participants | 815 Participants | 400 Participants |
| Sex: Female, Male Female | 244 Participants | 477 Participants | 233 Participants |
| Sex: Female, Male Male | 287 Participants | 570 Participants | 283 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 518 | 0 / 532 |
| other Total, other adverse events | 0 / 518 | 0 / 532 |
| serious Total, serious adverse events | 0 / 518 | 0 / 532 |
Outcome results
Primary
Time-dependent Rates of the Composite Primary Endpoint Major Adverse Cardiovascular Event (MACE: Comprising Cardiac-related Death or Acute Myocardial Infarction (AMI), and Revascularization)
To compare outcomes of participants with symptoms of stable angina or angina equivalent evaluated with an anatomic imaging strategy using CCTA as initial method of computer-aided diagnosis (CAD) (Group A) to a combined functional and anatomic imaging strategy of SPECT MPI/ICA (Group B) as a guide to Optimal Medical Therapy (OMT) alone. The analysis was conducted from an intent-to-treat perspective
Time frame: up to 24 Months (depends on time of trial enrollment and funding duration)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A: CCTA Diagnostic | Time-dependent Rates of the Composite Primary Endpoint Major Adverse Cardiovascular Event (MACE: Comprising Cardiac-related Death or Acute Myocardial Infarction (AMI), and Revascularization) | No Event | 487 Participants |
| Group A: CCTA Diagnostic | Time-dependent Rates of the Composite Primary Endpoint Major Adverse Cardiovascular Event (MACE: Comprising Cardiac-related Death or Acute Myocardial Infarction (AMI), and Revascularization) | Event Occurred | 29 Participants |
| Group B: SPECT MPI/ICA Diagnostic | Time-dependent Rates of the Composite Primary Endpoint Major Adverse Cardiovascular Event (MACE: Comprising Cardiac-related Death or Acute Myocardial Infarction (AMI), and Revascularization) | No Event | 504 Participants |
| Group B: SPECT MPI/ICA Diagnostic | Time-dependent Rates of the Composite Primary Endpoint Major Adverse Cardiovascular Event (MACE: Comprising Cardiac-related Death or Acute Myocardial Infarction (AMI), and Revascularization) | Event Occurred | 27 Participants |
p-value: 0.1995% CI: [0.61, 1.75]Regression, Cox
Secondary
Prediction of Response (MACE/Revascularization) at 1 Year Using: Modified Duke Score or CCTA + AHA 16 Predictor/CCTA+AHA 16+Clinical Data Predictor or SPECT% Reversible Defect Size Reported as Receiver Operating Characteristic (ROC) Area Under Curve (AUC)
AUC is a unitless measure of performance ranging form 0.5 (guessing) to 1.0 (perfect predictor) that can be thought of a the proportion of correct classifications in a 2-alternative-forced-choice experiment - and for binary outcomes, it is equivalent to the C-statistic. It will be used to evaluate and compare the ability of available prognostic indices and SPECT-MPI % reversible defect size to predict revascularization or MACE using CCTA information: A CCTA Modified Duke index A CCTA index including the 16 individual American Heart Association (AHA) segments A CCTA including the 16 individual AHA segments and clinical data and compare them to the SPECT % reversible defect size results
Time frame: 1 year
Population: For the secondary analyses, patients with \<1-year follow-up (defined as \<335 days) were excluded from analysis, as were ineligible patients and patients without the respective randomized scan or with an uninterpretable scan The analysis will compare the the proposed SPECT % reversible defect size vs the a modified Duke Score and the standard CCTA +AHA 16 to predict MACE events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: CCTA Diagnostic | Prediction of Response (MACE/Revascularization) at 1 Year Using: Modified Duke Score or CCTA + AHA 16 Predictor/CCTA+AHA 16+Clinical Data Predictor or SPECT% Reversible Defect Size Reported as Receiver Operating Characteristic (ROC) Area Under Curve (AUC) | 0.87 unitless |
| Group B: SPECT MPI/ICA Diagnostic | Prediction of Response (MACE/Revascularization) at 1 Year Using: Modified Duke Score or CCTA + AHA 16 Predictor/CCTA+AHA 16+Clinical Data Predictor or SPECT% Reversible Defect Size Reported as Receiver Operating Characteristic (ROC) Area Under Curve (AUC) | 0.92 unitless |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Prediction of Response (MACE/Revascularization) at 1 Year Using: Modified Duke Score or CCTA + AHA 16 Predictor/CCTA+AHA 16+Clinical Data Predictor or SPECT% Reversible Defect Size Reported as Receiver Operating Characteristic (ROC) Area Under Curve (AUC) | 0.93 unitless |
| Group B: SPECT % Reversible Defect Size | Prediction of Response (MACE/Revascularization) at 1 Year Using: Modified Duke Score or CCTA + AHA 16 Predictor/CCTA+AHA 16+Clinical Data Predictor or SPECT% Reversible Defect Size Reported as Receiver Operating Characteristic (ROC) Area Under Curve (AUC) | 0.73 unitless |
p-value: 0.08DeLong
p-value: 0.02DeLong
Secondary
Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score
SF36+SAQ at baseline and to a subset of participants, stratified by diagnostic examination, at 12 months after enrollment to monitor angina symptoms and their impact on Quality of life. The Short Form-36 (SF36) is a 36 item overall health status/Quality of Life collected in 8 domains. Scales are standardized with scores ranging from 0-100. Higher scores= better health status. The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item, cardiac disease-related quality-of-life measure collected in 5 domains. scales are standardized with scores ranging from 0-100. Higher scores= better health status. Positive cardiac findings on diagnostic testing are defined as: 1. 50% stenosis on CCTA or un-evaluable left main, or proximal and mid segments of all other epicardial arteries (right coronary artery, left anterior descending artery, or left circumflex artery); and 2. 10% reversible defect on SPECT MPI or evidence of Transient Ischemic Dilation (TID) accompanied by ECG
Time frame: baseline and 12 months
Population: Only cases with and an available screen result and both baseline and 1-year surveys completed are included in this analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Bodily pain: Baseline | 45.83 score on a scale | Standard Deviation 9.11 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF-36: Role-physical: Baseline | 46.07 score on a scale | Standard Deviation 10.22 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Physical limitation: 1-Year | 71.98 score on a scale | Standard Deviation 16.65 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Physical component: 1-Year | 47.44 score on a scale | Standard Deviation 10.66 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF-36: Phys Func: Baseline | 46.41 score on a scale | Standard Deviation 10.48 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF-36: Phys comp: Baseline | 45.41 score on a scale | Standard Deviation 9.27 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina stability: 1-Year | 80.31 score on a scale | Standard Deviation 28.17 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina frequency: Baseline | 77.38 score on a scale | Standard Deviation 15.24 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Disease perception: 1-Year | 79.03 score on a scale | Standard Deviation 20.16 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Treatment satisfaction: 1-Year | 87.40 score on a scale | Standard Deviation 17.89 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina frequency: 1-Year | 92.46 score on a scale | Standard Deviation 11.36 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina stability: Baseline | 44.34 score on a scale | Standard Deviation 31.42 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental comp: 1-Year | 50.11 score on a scale | Standard Deviation 10.82 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Bodily pain: 1-Year | 47.96 score on a scale | Standard Deviation 10.15 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Physical limitation: Baseline | 67.50 score on a scale | Standard Deviation 15.83 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Role-physical: 1-Year | 48.14 score on a scale | Standard Deviation 11.28 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Vitality: 1-Year | 50.09 score on a scale | Standard Deviation 40.51 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Physical functioning: 1-Year | 46.96 score on a scale | Standard Deviation 10.77 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental health: Baseline | 49.98 score on a scale | Standard Deviation 10.16 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Role emotional: Baseline | 47.9 score on a scale | Standard Deviation 12.07 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Social functioning: 1-Year | 48.72 score on a scale | Standard Deviation 11.15 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Disease perception: Baseline | 58.74 score on a scale | Standard Deviation 20.18 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Social functioning: Baseline | 46.60 score on a scale | Standard Deviation 10.63 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Vitality: Baseline | 48.11 score on a scale | Standard Deviation 10.23 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Role emotional: 1-Year | 48.43 score on a scale | Standard Deviation 11.07 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Treatment satisfaction: Baseline | 84.64 score on a scale | Standard Deviation 15.57 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental comp: Baseline | 49.42 score on a scale | Standard Deviation 11.15 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: General health: Baseline | 47.10 score on a scale | Standard Deviation 9.01 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental health: 1-Year | 50.17 score on a scale | Standard Deviation 10.24 |
| Group A: CCTA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: General health: 1-Year | 49.10 score on a scale | Standard Deviation 10.74 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental health: Baseline | 48.51 score on a scale | Standard Deviation 9.77 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Role-physical: 1-Year | 46.00 score on a scale | Standard Deviation 11.07 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Bodily pain: 1-Year | 46.62 score on a scale | Standard Deviation 10.16 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: General health: 1-Year | 46.40 score on a scale | Standard Deviation 10.86 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental comp: 1-Year | 48.11 score on a scale | Standard Deviation 10.96 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Vitality: 1-Year | 47.78 score on a scale | Standard Deviation 11.49 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Social functioning: 1-Year | 53.96 score on a scale | Standard Deviation 6.45 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Role emotional: 1-Year | 46.89 score on a scale | Standard Deviation 11.59 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental health: 1-Year | 48.26 score on a scale | Standard Deviation 10.38 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Physical limitation: 1-Year | 68.80 score on a scale | Standard Deviation 17.83 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina stability: 1-Year | 82.52 score on a scale | Standard Deviation 27.26 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina frequency: 1-Year | 92.59 score on a scale | Standard Deviation 14.71 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Treatment satisfaction: 1-Year | 86.85 score on a scale | Standard Deviation 20.74 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Disease perception: 1-Year | 77.58 score on a scale | Standard Deviation 21.77 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF-36: Phys comp: Baseline | 46.07 score on a scale | Standard Deviation 9.69 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF-36: Phys Func: Baseline | 47.16 score on a scale | Standard Deviation 9.98 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF-36: Role-physical: Baseline | 46.76 score on a scale | Standard Deviation 10.26 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Bodily pain: Baseline | 45.87 score on a scale | Standard Deviation 8.72 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: General health: Baseline | 46.43 score on a scale | Standard Deviation 9.51 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental comp: Baseline | 48.52 score on a scale | Standard Deviation 10.64 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Vitality: Baseline | 46.75 score on a scale | Standard Deviation 10.9 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Social functioning: Baseline | 47.25 score on a scale | Standard Deviation 10.42 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Role emotional: Baseline | 48.08 score on a scale | Standard Deviation 11.12 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Physical limitation: Baseline | 67.12 score on a scale | Standard Deviation 17.2 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina stability: Baseline | 48.87 score on a scale | Standard Deviation 32.71 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina frequency: Baseline | 79.79 score on a scale | Standard Deviation 15.4 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Treatment satisfaction: Baseline | 85.87 score on a scale | Standard Deviation 15.95 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Disease perception: Baseline | 59.33 score on a scale | Standard Deviation 19.81 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Physical component: 1-Year | 46.39 score on a scale | Standard Deviation 10.4 |
| Group B: SPECT MPI/ICA Diagnostic | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Physical functioning: 1-Year | 47.35 score on a scale | Standard Deviation 10.46 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental health: Baseline | 47.83 score on a scale | Standard Deviation 9.36 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental health: 1-Year | 46.45 score on a scale | Standard Deviation 11.58 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental comp: 1-Year | 46.69 score on a scale | Standard Deviation 11.5 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Physical functioning: 1-Year | 46.56 score on a scale | Standard Deviation 9.31 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Physical limitation: Baseline | 65.20 score on a scale | Standard Deviation 16.67 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Disease perception: Baseline | 54.38 score on a scale | Standard Deviation 19.06 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Vitality: Baseline | 47.9 score on a scale | Standard Deviation 9.86 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Physical component: 1-Year | 47.27 score on a scale | Standard Deviation 8.66 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina stability: Baseline | 40.98 score on a scale | Standard Deviation 30.32 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Bodily pain: 1-Year | 45.91 score on a scale | Standard Deviation 10.13 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: General health: 1-Year | 46.84 score on a scale | Standard Deviation 9.84 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Social functioning: 1-Year | 48.54 score on a scale | Standard Deviation 10.77 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina frequency: 1-Year | 86.00 score on a scale | Standard Deviation 16.46 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: General health: Baseline | 46.17 score on a scale | Standard Deviation 8.13 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Social functioning: Baseline | 46.86 score on a scale | Standard Deviation 9.4 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina frequency: Baseline | 74.25 score on a scale | Standard Deviation 16.15 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Treatment satisfaction: 1-Year | 84.90 score on a scale | Standard Deviation 18.42 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF-36: Role-physical: Baseline | 45.77 score on a scale | Standard Deviation 8.79 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina stability: 1-Year | 71.71 score on a scale | Standard Deviation 30.98 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Role emotional: 1-Year | 46.25 score on a scale | Standard Deviation 9.84 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Disease perception: 1-Year | 71.04 score on a scale | Standard Deviation 23.64 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Bodily pain: Baseline | 46.31 score on a scale | Standard Deviation 7.94 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Role emotional: Baseline | 44.96 score on a scale | Standard Deviation 10.16 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental comp: Baseline | 47.09 score on a scale | Standard Deviation 9.55 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF-36: Phys comp: Baseline | 46.10 score on a scale | Standard Deviation 8.51 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Vitality: 1-Year | 48.72 score on a scale | Standard Deviation 11.15 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Physical limitation: 1-Year | 66.61 score on a scale | Standard Deviation 17.39 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Role-physical: 1-Year | 48.38 score on a scale | Standard Deviation 9.2 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF-36: Phys Func: Baseline | 46.4 score on a scale | Standard Deviation 9361 |
| Group A: CCTA + AHA 16 + Clinical Data Predictor | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Treatment satisfaction: Baseline | 85.85 score on a scale | Standard Deviation 15.41 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF-36: Phys Func: Baseline | 46.3 score on a scale | Standard Deviation 12.37 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF-36: Role-physical: Baseline | 48.04 score on a scale | Standard Deviation 10.07 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Treatment satisfaction: Baseline | 82.94 score on a scale | Standard Deviation 11.91 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Bodily pain: Baseline | 45.55 score on a scale | Standard Deviation 9.65 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Role emotional: 1-Year | 52.38 score on a scale | Standard Deviation 7.87 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: General health: Baseline | 50.31 score on a scale | Standard Deviation 5.08 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Physical functioning: 1-Year | 51.77 score on a scale | Standard Deviation 5.97 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental comp: Baseline | 49.46 score on a scale | Standard Deviation 6.91 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Social functioning: 1-Year | 46.72 score on a scale | Standard Deviation 11.21 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Vitality: Baseline | 46.75 score on a scale | Standard Deviation 10.9 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Disease perception: Baseline | 62.50 score on a scale | Standard Deviation 19.74 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Social functioning: Baseline | 49.76 score on a scale | Standard Deviation 5.17 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Vitality: 1-Year | 53.96 score on a scale | Standard Deviation 6.45 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Role-physical: 1-Year | 53.42 score on a scale | Standard Deviation 4.65 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Role emotional: Baseline | 48.51 score on a scale | Standard Deviation 9.77 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental comp: 1-Year | 53.51 score on a scale | Standard Deviation 6.93 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental health: Baseline | 50.01 score on a scale | Standard Deviation 7.39 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Physical limitation: Baseline | 67.41 score on a scale | Standard Deviation 17.36 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: General health: 1-Year | 53.55 score on a scale | Standard Deviation 7.64 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina stability: Baseline | 38.00 score on a scale | Standard Deviation 27.41 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Physical component: 1-Year | 52.51 score on a scale | Standard Deviation 5.04 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina frequency: 1-Year | 97.00 score on a scale | Standard Deviation 6.75 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina stability: 1-Year | 92.00 score on a scale | Standard Deviation 19.32 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Treatment satisfaction: 1-Year | 97.65 score on a scale | Standard Deviation 3.04 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Angina frequency: Baseline | 75.00 score on a scale | Standard Deviation 15.81 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Disease perception: 1-Year | 91.67 score on a scale | Standard Deviation 13.61 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SAQ: Physical limitation: 1-Year | 76.30 score on a scale | Standard Deviation 10.77 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Bodily pain: 1-Year | 53.03 score on a scale | Standard Deviation 7.14 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF-36: Phys comp: Baseline | 47.2 score on a scale | Standard Deviation 9.19 |
| Group B: SPECT % Reversible Defect Size | Short Form-36 Survey (SF-36v2) and Seattle Angina Questionnaire (SAQ) Score | SF36: Mental health: 1-Year | 54.23 score on a scale | Standard Deviation 6.4 |
Secondary
The Effectiveness of Each Arm Will be Measured in Terms of Life Years and Quality of Life Years (QALY).
International medical records will be used to determine mortality which may not be feasible at all participating international sites. Utilities will be based on Quality of Well Being scores converted from the SF-36 assessments The analysis will be performed assuming a societal perspective and lifetime time horizon
Time frame: Baseline and 1 year
Population: The study was terminated before data to compute life years was collected SF-36 scores have been reported previously