An interventional study of 64 Channel VCT in Coronary Artery Disease, sponsored by GE Healthcare. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-23.
Sponsored by GE Healthcare · Not applicable, Interventional, and Diagnostic
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.
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:
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.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 249 is above the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →GE Healthcare is the lead sponsor of 175 studies on the registry; 20 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
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Exclusion Criteria:
The subject has hemodynamic or active clinical instability:
General imaging subjects receiving CT exams
Device: 64 Channel VCT
cardiac CT angiography exam
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
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
| Milestone | Imaging |
|---|---|
| Started | 249 |
| Completed | 249 |
| Not completed | 0 |
Number of subjects with CT for detection purposes
| Measure | Enrolled |
|---|---|
| Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth. | 0 |
| Measure | Outcome Measure 2 |
|---|---|
| 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 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enrolled | — | 0/249 (0%) | 0/249 (0%) |
All subjects
| Age, Continuous(years) | Imaging |
|---|---|
| Mean | 30 (18 to 80) |
| Sex: Female, Male(Participants) | Imaging |
|---|---|
| Female | 0 |
| Male | 0 |
This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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