Coronary Artery Disease
Conditions
Brief summary
To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of CAD.
Detailed description
This study is a prospective, multi-center, within-subject comparative study. One hundred fifty (150) subjects with CATH procedures are needed in the study. Approximately 300 subjects who meet all of the inclusion/exclusion criteria will be enrolled. The study population will consist of subjects with symptoms suspected of and at intermediate-risk for ischemic heart disease, which are referred for MPS for a definitive diagnosis of CAD. Each subject will undergo the following procedures: * A Myocardial Perfusion Study (MPS) procedure, as standard of care; * An IV contrast-enhanced cardiac CT (CCTA) procedure; * A CATH procedure when the MPS and/or cardiac CT examination is deemed positive or equivocal and at the discretion of the referring physicians, as a standard-of-care procedure. When both the MPS and CCTA are normal, the subject is not required to undergo a CATH procedure, but will enter into follow-up. The research staff at each site will perform follow-up for each subject at 12 months (± 15 days) and 24 months (± 15 days) and 36 months (± 15 days) after the completion of the cardiac CT procedure.
Interventions
DEVICE64 Channel VCT
cardiac CT angiography exam
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with an intermediate probability risk for coronary artery disease. * Subject has symptoms of suspected ischemic heart disease. * Subject is at intermediate risk for coronary artery disease
Exclusion criteria
* The subject has undergone a prior CCTA within 6 months prior to entering the study. * The subject has a documented history of CAD by CATH, myocardial infarction (MI), metal stent placement in any of the coronary vessels, or a previous coronary artery bypass graft (CABG) procedure * The subject has hemodynamic or active clinical instability: * Acute chest pain (sudden onset); * Cardiac shock; * Unstable blood pressure (BP); * Severe congestive heart failure or acute pulmonary edema.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth. | through study completion, an expected average of 1 year | Number of subjects with CT for detection purposes |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Outcomes - EKG, Laboratory Workup, Changes in Medical Management, Downstream Cardiac Testing, Significant Coronary Interventions, and Major Cardiac Events & Long-term Outcomes (Non-fatal MI and Cardiac-related Death). | 1 year outcomes after initial MPS exam |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Imaging General imaging subjects receiving CT exams
64 Channel VCT: cardiac CT angiography exam | 249 |
| Total | 249 |
Baseline characteristics
| Characteristic | Imaging |
|---|---|
| Age, Continuous | 30 years |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 249 |
| serious Total, serious adverse events | 0 / 249 |
Outcome results
Primary
Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth.
Number of subjects with CT for detection purposes
Time frame: through study completion, an expected average of 1 year
Population: Data were not collected for analysis.
| Arm | Measure | Value |
|---|---|---|
| Enrolled | Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth. | 0 |
Secondary
Clinical Outcomes - EKG, Laboratory Workup, Changes in Medical Management, Downstream Cardiac Testing, Significant Coronary Interventions, and Major Cardiac Events & Long-term Outcomes (Non-fatal MI and Cardiac-related Death).
Time frame: 1 year outcomes after initial MPS exam
Population: Data were not collected for analysis.
| Arm | Measure | Value |
|---|---|---|
| Enrolled | Clinical Outcomes - EKG, Laboratory Workup, Changes in Medical Management, Downstream Cardiac Testing, Significant Coronary Interventions, and Major Cardiac Events & Long-term Outcomes (Non-fatal MI and Cardiac-related Death). | 0 |