Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia

Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia (The CREDENCE Trial)

The study seeks to determine the accuracy of using anatomic and physiologic information measurable by computed tomography features of stenosis, plaque, fractional flow reserve-CT and to compare this measure to stress testing for the detection of myocardial ischemia against the gold standard of cardiac catheterization with fractional flow reserve. The hypothesis of this proposal is that integrating anatomic plaque features with physiologic fractional flow reserve-CT will optimize identification of coronary lesions that are ischemia-causing by computed tomography .

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