Acute Coronary Syndrome, Chest Pain, Heart Disease, Coronary
Conditions
Keywords
angina, coronary artery disease, coronary artery catheterization, coronary CT angiography, fractional flow reserve CT, emergency department
Brief summary
This study is designed to directly compare Standard Care and CT fractional flow reserve (CTFFR) for diagnosis of chest pain patients with definite coronary artery disease (CAD) on heart computed tomography (CT) scans.
Detailed description
New or worsening chest discomfort is the most common symptom of coronary artery disease (CAD), which is plaque build-up in the arteries that supply the heart muscle with blood. Chest pain is one of the most common reasons for emergency department (ED) visits, with an estimated 8 million new cases every year. Evaluation of chest pain is expensive and time consuming, even though 75% of the time it is not due to CAD. It is necessary to carefully define the amount of CAD, even if initial tests reveal no heart attack, because this symptom may progress to heart attack and death if missed. Coronary artery computed tomography angiography of the heart (CCTA) is one of the most sensitive tests to detect serious CAD in appropriately selected patients.In 85% of acute chest pain (ACP) ED cases tested by CCTA, no CAD or very mild CAD is found, leading to rapid discharge or an alternative diagnosis. However, in the 15% of patients with significant CAD found on CCTA, further evaluation with either stress testing or heart catheterization, and/or hospital admission is required. Since 2015, Beaumont Health hospitals have employed a new FDA-approved test, called CT fractional flow reserve (CTFFR), that can analyze flow down the heart arteries by computer analysis of the original CT images. Results from an analysis of 147 patients suggest that 67% of the time, CTFFR showed no significant flow limitation, providing for the potential to defer invasive testing or treatment for a trial of medical therapy. The use of CTFFR on ED patients is novel, and it is not yet part of the standard of care (SOC). Standard care of patients with definite CAD on CCTA continues to be hospital admission, stress testing and/or heart catheterization for further diagnosis. Both CTFFR and standard care continue to be used at Beaumont Health, and it is important to determine if one or the other diagnostic strategy is superior. This study is designed to directly compare standard care and CTFFR for diagnosis and management of ACP patients with definite CAD on CCTA.
Interventions
DIAGNOSTIC_TESTCTFFR-Guided Group Management
Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.
DIAGNOSTIC_TESTSOC Group Management
Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment
Sponsors
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Emergency department chest pain suspicious for ACS based on history and physical examination. * At least one biomarker (troponin) and electrocardiogram with no evidence of definite ACS. * A completed CCTA demonstrating \>50% but \<90% stenosis of at least one coronary artery branch. * CCTA test images with sufficient diagnostic quality for CTFFR analysis. * Ability and willingness to provide informed consent.
Exclusion criteria
* Left main coronary stenosis of 50% or greater. * CCTA lesions demonstrating stenosis \>90% (subtotal), or complex, high-risk plaque characteristics resulting in an a priori recommendation for triage to CATH by the CCTA interpreting physician. * Attending physician a priori decision for CATH. * Previous coronary stent, coronary bypass or prior known myocardial infarction. * Clinical instability, such as hypotension, signs of shock, and/or accelerating chest pain requiring admission. * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catheterization Rate | 3 months after initial presentation | Percent of patients undergoing heart catheterization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Effectiveness | 3 months after initial presentation | Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy |
| Incidence of Major Adverse Cardiac Events | 1 year after presentation | Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization |
| Hospital Length of Stay | An average of 2 days | Time from admission to discharge from hospital in days |
Countries
United States
Participant flow
Recruitment details
Emergency department patients who had a Cardiac CT scan, were screened for the study. The doctors interpreting the CT scan notifies the research coordinator regarding potential eligibility of the patient to the study.
Participants by arm
| Arm | Count |
|---|---|
| SOC Group Management Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.
SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment | 5 |
| CTFFR-Guided Group Management Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.
CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway. | 6 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Elevated Troponin (failed screen) | 1 | 0 |
| Overall Study | Study Termination | 5 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | CTFFR-Guided Group Management | Total | SOC Group Management |
|---|---|---|---|
| Age, Continuous | 60.5 years | 57 years | 52 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 6 Participants | 11 Participants | 5 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
Primary
Catheterization Rate
Percent of patients undergoing heart catheterization
Time frame: 3 months after initial presentation
Population: Study terminated with NO data collected.
Secondary
Diagnostic Effectiveness
Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy
Time frame: 3 months after initial presentation
Population: Study terminated with NO data collected.
Secondary
Hospital Length of Stay
Time from admission to discharge from hospital in days
Time frame: An average of 2 days
Population: Study terminated with NO data collected.
Secondary
Incidence of Major Adverse Cardiac Events
Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization
Time frame: 1 year after presentation
Population: Study terminated with NO data collected.