Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia

Conditions

Myocardial Ischemia

Brief summary

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 .

Detailed description

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.

Isabella Lipkin, Anha Telluri, Yumin Kim, Alfateh Sidahmed, Joseph M. Krepp et al. (40 authors)

American Journal of Roentgenology2022-04-2042 citations

10.2214/ajr.21.27289

AI Evaluation of Stenosis on Coronary CTA, Comparison With Quantitative Coronary Angiography and Fractional Flow Reserve: A CREDENCE Trial Substudy.

Griffin WF, Choi AD, Riess JS, Marques H, Chang HJ, Choi JH, Doh JH, Her AY, Koo BK, Nam CW, Park HB, Shin SH, Cole J, Gimelli A, Khan MA, Lu B, Gao Y, Nabi F, Nakazato R, Schoepf UJ, Driessen RS, Bom MJ, Thompson R, Jang JJ, Ridner M, Rowan C, Avelar E, Généreux P, Knaapen P, de Waard GA, Pontone G, Andreini D, Earls JP.

2022-02-16106 citations

10.1016/j.jcmg.2021.10.020

Stress Myocardial Perfusion Imaging vs Coronary Computed Tomographic Angiography for Diagnosis of Invasive Vessel-Specific Coronary Physiology

Wijnand J. Stuijfzand, Alexander R. van Rosendael, Fay Y. Lin, Hyuk‐Jae Chang, Inge J. van den Hoogen et al. (41 authors)

JAMA Cardiology2020-08-1975 citations

10.1001/jamacardio.2020.3409

Rationale and Design of the CREDENCE Trial: computed TomogRaphic evaluation of atherosclerotic DEtermiNants of myocardial IsChEmia

Asim Rizvi, Bríain ó Hartaigh, Paul Knaapen, Jonathon Leipsic, Leslee J. Shaw et al. (24 authors)

BMC Cardiovascular Disorders2016-10-0629 citations

10.1186/s12872-016-0360-x

What is the future of Cardiac CT?

Bin Lü

RöFo - Fortschritte auf dem Gebiet der Röntgenstrahlen und der bildgebenden Verfahren2016-03-29

10.1055/s-0036-1581365

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy of vessel territory-specific ischemia of an integrated stenosis-APC-FFRCT measure by CT	48-60 months	The primary endpoint is the diagnostic accuracy of an integrated stenosis-APC-FFRCT metric by CT, as compared to perfusion or perfusion-MBF stress imaging testing for vessel territory-specific ischemia as determined by FFR (gold standard).

Secondary

Measure	Time frame	Description
Individual comparisons of APCs or FFRCT to MPI vessel-specific perfusion deficits or reduced MBF.	48-60 months	To compare the accuracy of the individual components of APCs or FFRCT to MPI vessel-specific perfusion deficits or reduced MBF against ischemia by FFR.
Post-PCI FFR prediction by FFRCT virtual stenting	48-60 months	To determine the accuracy of FFRCT virtual stenting to post-PCI FFR value of \>0.80 and determine the correlation between the FFRCT virtual stenting to post-PCI FFR.

Countries

Canada, China, Italy, Japan, Latvia, Netherlands, South Korea, United States

Outcome results