Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Multidetector Computed Tomography, Myocardial Perfusion Imaging
Brief summary
The investigators propose a novel technique using dual source multidetector computed tomography (DSCT) where information on both coronary anatomy and myocardial perfusion is obtained in a single scan. The investigators hypothesize that a coronary CTA protocol can be devised to obtain resting myocardial perfusion, myocardial perfusion after stress, and coronary anatomy. Hence, one diagnostic test will be able to detect the presence of coronary plaque as well as assess the functional significance of a stenosis.
Interventions
OTHERAdenosine Stress Dual-source CTP
Adenosine- continuous infusion at 140mcg/ kg/ min for 2.5 min; Iopamidol (IV contrast)- total dose of 150cc; Siemens SOMATOM Definition CT scanner (CT scan radiation) - effective radiation dose of approximately 13mSv (tube voltage 120kV, tube current 340mAs for one retrospectively gated cardiac CT with tube current modulation and two prospectively gated cardiac CTs on a Dual Source scanner) This is an observational trial, and all patients will undergo the Adenosine Stress Dual-source CTP procedure.
Sponsors
Astellas Pharma Inc
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* A prior adenosine or exercise stress SPECT exam with high likelihood of being referred to the cardiac catheterization laboratory for invasive angiogram * Age \> 40 years old * Able to comprehend and sign the consent form.
Exclusion criteria
* Acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction, ST elevation myocardial infarction) * Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias) * Premenopausal women who have a positive pregnancy test. * Serum Creatinine level ≥1.5 mg/dl as an indicator of renal insufficiency. * Known allergy to iodinated contrast agents * Atrial fibrillation * Asthma * Critical aortic stenosis * Systolic blood pressure \< 90 mmHg * Advanced heart block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography. | 18 months | The gold standard for abnormality by CTP is defined as a focal stenosis of \>50% at quantitative analysis of invasive coronary angiography images, when performed. |
| Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography. | 18 months | The gold standard for abnormality by CTP is defined as stenosis of 50% or more at quantitative analysis of invasive coronary angiography images, when performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Per-Patient Correlation Between CTP and SPECT at Stress. | 18 months | Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress. |
| Per-Patient Correlation Between CTP and SPECT at Rest. | 18 months | Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: 3/3/2008 - 7/1/2009
Participants by arm
| Arm | Count |
|---|---|
| Myocardial Stress CT Perfusion Imaging Patients who will undergo myocardial stress CT perfusion imaging. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Myocardial Stress CT Perfusion Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age, Continuous | 62.3 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
The gold standard for abnormality by CTP is defined as a focal stenosis of \>50% at quantitative analysis of invasive coronary angiography images, when performed.
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myocardial Stress CT Perfusion Imaging | Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography. | 79 percentage of participants |
Primary
Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
The gold standard for abnormality by CTP is defined as stenosis of 50% or more at quantitative analysis of invasive coronary angiography images, when performed.
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myocardial Stress CT Perfusion Imaging | Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography. | 80 percentage of participants |
Secondary
Per-Patient Correlation Between CTP and SPECT at Rest.
Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest.
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myocardial Stress CT Perfusion Imaging | Per-Patient Correlation Between CTP and SPECT at Rest. | 0.76 correlation coefficient |
Comparison: Pearson Correlationp-value: <0.0001Pearson Correlation
Secondary
Per-Patient Correlation Between CTP and SPECT at Stress.
Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress.
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Myocardial Stress CT Perfusion Imaging | Per-Patient Correlation Between CTP and SPECT at Stress. | 0.60 correlation coefficient |
p-value: <0.0001Pearson Correlation