Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization

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

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.

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.

INCLUSION CRITERIA

1. Age >18 years
2. Patients providing written informed consent
3. Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography with an ACC/AHA Class II indication

EXCLUSION CRITERIA

1. Known CAD (myocardial infarction, PCI, CABG)
2. ACC/AHA Class I or III indication for ICA
3. Non-cardiac illness with life expectancy <2 years
4. Inability to provide written informed consent
5. Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
6. Pregnant women
7. Allergy to iodinated contrast agent
8. Serum creatinine ≥1.5 mg/dl or Glomerular Filtration Rate <30 ml/min
9. Uncontrolled Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
10. 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