Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia

The CREDENCE trial will be a prospective multicenter cross-sectional study of 618 individuals
(n=309 [derivation cohort]; n=309 [validation cohort]) who will undergo stress test, computed
tomography, cardiac catheterization and fractional flow reserve. For the purposes of the
study, either stress test or computed tomography will have been performed for clinical
purposes, with the other test being performed as part of trial procedure. Study analyses will
focus on the diagnostic performance of the information derived by stress test versus computed
tomography against an invasive gold standard of cardiac catheterization and fractional flow
reserve for an endpoint of vessel territory-specific ischemia. In keeping with prior studies,
vessel territories will be comprised of the left anterior descending artery (and diagonal
branches), the left circumflex artery (and obtuse marginal branches) and the right coronary
artery (and posterolateral branch and posterior descending artery).

To date, the relative performance of traditional stress imaging testing compared to the
entirety of information proffered by CT has not been assessed compared to an unbiased gold
standard. The study proposed herein will directly address this unmet need.

Inclusion Criteria:

1. Age >18 years

2. Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography

Exclusion Criteria:

1. Known CAD (myocardial infarction [MI], percutaneous coronary interventions [PCIs],
coronary artery bypass graft [CABG],)

2. Hemodynamic instability

3. Inability to provide written informed consent

4. Concomitant participation in another clinical trial in which subject is subject to
investigational drug or device

5. Pregnant state

6. Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid
reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent)

7. Serum creatinine ≥1.7 mg/dl or Glomerular Filtration Rate <30 ml/min

8. Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)

9. Heart rate ≥100 beats per minute

10. Systolic blood pressure ≤90 mm Hg

11. Contraindications to β blockers or nitroglycerin or adenosine

12. BMI >40 kg/m2