Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia
Completed
Conditions studied: Myocardial Ischemia
In brief
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 .
Key facts
- Study ID
- NCT02173275
- Run by
- Weill Medical College of Cornell University
- People needed
- 618
- Starts
- 2014-05-01
- Expected to finish
- 2018-01-18
- Last updated by the study team
- 2019-11-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Heart Center Research, LLC — Huntsville, Alabama, United States
- Mobile Cardiology Associates — Mobile, Alabama, United States
- Kaiser Permanente Hospital — San Jose, California, United States
- Oconee Heart and Vascular Center at St Mary's Hospital — Athens, Georgia, United States
- St. Luke's Lipid and Diabetes Research Center — Kansas City, Missouri, United States
- Renown Heart and Vascular — Reno, Nevada, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Houston Methodist Hospital — Houston, Texas, United States
- Cardiac Center of Texas — McKinney, Texas, United States
- Multicare HS Institute for Research & Innovation — Tacoma, Washington, United States
- Providence Health Care- St. Paul's Hospital; University of British Columbia — Vancouver, British Columbia, Canada
- 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
- Centro Cardiologico Monzino, IRCCS and University of Milan — Milan, Italy
- Fondazione Toscana Gabriele Monasterio — Pisa, Italy
- St. Luke's Hospital — Tokyo, Japan
- Paul Stradins University Hospital — Riga, Latvia
- VU University Medical Center — Amsterdam, Netherlands
- Severance Cardiovascular Hospital — Seoul, South Korea
Full record on ClinicalTrials.gov
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