Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia

NCT02173275 | Completed DMC

• 2 other identifiers: 1309014313R01HL118019
• Study Type: observational
• Target: 618
• Locations: 8 countries
• Sites: 18

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 .

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Individual comparisons of APCs or FFRCT to MPI vessel-specific perfusion deficits or reduced MBF.

  48-60 months

• Post-PCI FFR prediction by FFRCT "virtual stenting"

  48-60 months

Study Arms (2)

derivation cohort

n = 309

validation cohort

n = 309

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive consenting adult patients who meet all of the inclusion criteria and none of the exclusion criteria will be asked to participate in the study.

You may qualify if:

• Age \>18 years
• Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography

You may not qualify if:

• Known CAD (myocardial infarction \[MI\], percutaneous coronary interventions \[PCIs\], coronary artery bypass graft \[CABG\],)
• Hemodynamic instability
• Inability to provide written informed consent
• Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
• Pregnant state
• Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent)
• Serum creatinine ≥1.7 mg/dl or Glomerular Filtration Rate \<30 ml/min
• Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
• Heart rate ≥100 beats per minute
• Systolic blood pressure ≤90 mm Hg
• Contraindications to β blockers or nitroglycerin or adenosine
• BMI \>40 kg/m2

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (18)

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

Location

Mobile Cardiology Associates

Mobile, Alabama, 36608, United States

Location

Kaiser Permanente Hospital

San Jose, California, 95119, United States

Location

Oconee Heart and Vascular Center at St Mary's Hospital

Athens, Georgia, 30606, United States

Location

St. Luke's Lipid and Diabetes Research Center

Kansas City, Missouri, 64111, United States

Location

Renown Heart and Vascular

Reno, Nevada, 89502, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Cardiac Center of Texas

McKinney, Texas, 75069, United States

Location

Multicare HS Institute for Research & Innovation

Tacoma, Washington, 98372, United States

Location

Providence Health Care- St. Paul's Hospital; University of British Columbia

Vancouver, British Columbia, Canada

Location

State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Location

Centro Cardiologico Monzino, IRCCS and University of Milan

Milan, Italy

Location

Fondazione Toscana Gabriele Monasterio

Pisa, Italy

Location

St. Luke's Hospital

Tokyo, Japan

Location

Paul Stradins University Hospital

Riga, Latvia

Location

VU University Medical Center

Amsterdam, Netherlands

Location

Severance Cardiovascular Hospital

Seoul, South Korea

Location

Related Publications (4)

• Rizvi A, Hartaigh BO, 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. doi: 10.1186/s12872-016-0360-x.

  PMID: 27716131 BACKGROUND

• Lipkin I, Telluri A, Kim Y, Sidahmed A, Krepp JM, Choi BG, Jonas R, 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, Jang JJ, Ridner M, Rowan C, Avelar E, Genereux P, Knaapen P, de Waard GA, Pontone G, Andreini D, Al-Mallah MH, Crabtree TR, Earls JP, Choi AD, Min JK. Coronary CTA With AI-QCT Interpretation: Comparison With Myocardial Perfusion Imaging for Detection of Obstructive Stenosis Using Invasive Angiography as Reference Standard. AJR Am J Roentgenol. 2022 Sep;219(3):407-419. doi: 10.2214/AJR.21.27289. Epub 2022 Apr 20.

  PMID: 35441530 DERIVED

• 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, Genereux P, Knaapen P, de Waard GA, Pontone G, Andreini D, Earls JP. AI Evaluation of Stenosis on Coronary CTA, Comparison With Quantitative Coronary Angiography and Fractional Flow Reserve: A CREDENCE Trial Substudy. JACC Cardiovasc Imaging. 2023 Feb;16(2):193-205. doi: 10.1016/j.jcmg.2021.10.020. Epub 2022 Feb 16.

  PMID: 35183478 DERIVED

• Stuijfzand WJ, van Rosendael AR, Lin FY, Chang HJ, van den Hoogen IJ, Gianni U, 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, Genereux P, Knaapen P, de Waard GA, Pontone G, Andreini D, Al-Mallah MH, Lu Y, Berman DS, Narula J, Min JK, Bax JJ, Shaw LJ; CREDENCE Investigators. Stress Myocardial Perfusion Imaging vs Coronary Computed Tomographic Angiography for Diagnosis of Invasive Vessel-Specific Coronary Physiology: Predictive Modeling Results From the Computed Tomographic Evaluation of Atherosclerotic Determinants of Myocardial Ischemia (CREDENCE) Trial. JAMA Cardiol. 2020 Dec 1;5(12):1338-1348. doi: 10.1001/jamacardio.2020.3409.

  PMID: 32822476 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Leslee J Shaw, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 24, 2014
• Study Start: May 1, 2014
• Primary Completion: May 9, 2017
• Study Completion: January 18, 2018
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

LA (1); NL (1); CN (1); CA (1); US (10); IT (2); KR (1); JP (1)