Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia

Myocardial Ischemia Clinical Trial

— CREDENCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173275
• Other study ID #: 1309014313
• Secondary ID: R01HL118019
• Status: Completed
• Start date: May 2014
• Est. completion date: January 18, 2018

Study information

• Verified date: November 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 618
• Est. completion date: January 18, 2018
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß blockers or nitroglycerin or adenosine

12. BMI >40 kg/m2

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Locations

Country	Name	City	State
Canada	Providence Health Care- St. Paul's Hospital; University of British Columbia	Vancouver	British Columbia
China	State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing
Italy	Centro Cardiologico Monzino, IRCCS and University of Milan	Milan
Italy	Fondazione Toscana Gabriele Monasterio	Pisa
Japan	St. Luke's Hospital	Tokyo
Korea, Republic of	Severance Cardiovascular Hospital	Seoul
Latvia	Paul Stradins University Hospital	Riga
Netherlands	VU University Medical Center	Amsterdam
United States	Oconee Heart and Vascular Center at St Mary's Hospital	Athens	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Houston Methodist Hospital	Houston	Texas
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	St. Luke's Lipid and Diabetes Research Center	Kansas City	Missouri
United States	Cardiac Center of Texas	McKinney	Texas
United States	Mobile Cardiology Associates	Mobile	Alabama
United States	Renown Heart and Vascular	Reno	Nevada
United States	Kaiser Permanente Hospital	San Jose	California
United States	Multicare HS Institute for Research & Innovation	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada,  China,  Italy,  Japan,  Korea, Republic of,  Latvia,  Netherlands, 

References & Publications (1)

Rizvi A, Hartaigh BÓ, Knaapen P, Leipsic J, Shaw LJ, Andreini D, Pontone G, Raman S, Khan MA, Ridner M, Nabi F, Gimelli A, Jang J, Cole J, Nakazato R, Zarins C, Han D, Lee JH, Szymonifika J, Gomez MJ, Truong QA, Chang HJ, Lin FY, Min JK. Rationale and Design of the CREDENCE Trial: computed TomogRaphic evaluation of atherosclerotic DEtermiNants of myocardial IsChEmia. BMC Cardiovasc Disord. 2016 Oct 6;16(1):190. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of vessel territory-specific ischemia of an integrated stenosis-APC-FFRCT measure by CT	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).	48-60 months
Secondary	Individual comparisons of APCs or FFRCT to MPI vessel-specific perfusion deficits or reduced MBF.	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.	48-60 months
Secondary	Post-PCI FFR prediction by FFRCT "virtual stenting"	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.	48-60 months