Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization

Study Overview
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Brief Summary
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To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography.

Detailed Description
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A prospective, randomized controlled multicenter trial to determine the clinical and cost effectiveness of a selective catheterization strategy versus a direct catheterization strategy for stable patients with suspected but without known CAD and clinical indication for non-emergent invasive coronary angiography. Subjects in the selective catheterization arm will be followed for a primary endpoint of non-inferiority for rates of major adverse cardiac events (MACE) as compare to subjects in the direct catheterization strategy.

Official Title
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Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization: Relation to CardioVascular Outcomes, Cost Effectiveness and Quality of Life

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Cardiac CT
* Procedure: Invasive Coronary Angiography


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Age >18 years Patients providing written informed consent Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography with an ACC/AHA Class II indication EXCLUSION CRITERIA Known CAD (myocardial infarction, PCI, CABG) ACC/AHA Class I or III indication for ICA Non-cardiac illness with life expectancy <2 years Inability to provide written informed consent Concomitant participation in another clinical trial in which subject is subject to investigational drug or device Pregnant women Allergy to iodinated contrast agent Serum creatinine ≥1.5 mg/dl or Glomerular Filtration Rate <30 ml/min Uncontrolled Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.) Heart rate ≥100 beats per minute 12) Systolic blood pressure ≤90 mm Hg 13) Contraindications to β blockers or nitroglycerin 14) Known complex congenital heart disease 15) Body mass index >35

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cardiac CT<br>Patients who undergo Cardiac CT (instead of Invasive Coronary Angiography) | Procedure: Cardiac CT<br>* Perform a non-invasive Cardiac CT Angiogram<br>|
| Active Comparator: Invasive Coronary Angiography<br>Patients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography | Procedure: Invasive Coronary Angiography<br>* Patient undergoes Invasive Coronary Angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE Endpoints | Death Non-fatal myocardial infarction Unstable angina (including new onset angina or those requiring hospitalization, revascularization or that are troponin-positive) Stroke Urgent or emergent coronary revascularization Cardiovascular hospitalization (including for angina, heart failure or other) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional MACE Endpoints | The primary composite MACE endpoint plus major bleeding. The primary composite MACE endpoint plus major bleeding or need for urgent/ emergent surgery due to hemorrhage. The primary composite MACE endpoint plus major bleeding plus need for urgent/ emergent surgery due to hemorrhage plus need for major transfusion. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Cardiac CT, Catheterization