Comprehensive Evaluation of Ischemic Heart Disease Using MRI
Completed · Phase 2/Phase 3
Conditions studied: Heart Disease, Ischemic, Atherosclerosis, Coronary
In brief
The purpose of the study is to assess the diagnostic performance of fully automated motion corrected (MC) first pass myocardial perfusion MRI, compared to the original non-corrected first pass myocardial perfusion images in a cohort of patients with suspected ischemic heart disease, using coronary angiography as the reference standard. It is expected that this improved comprehensive protocol for cardiac MRI be accurate at detecting significant coronary artery disease and may obviate the need for other more expensive and invasive diagnostic tests currently used.
Key facts
- Study ID
- NCT01234870
- Run by
- Northwestern University
- People needed
- 40
- Starts
- 2010-06-01
- Expected to finish
- 2012-01-01
- Last updated by the study team
- 2014-09-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Under an Institutional Committee on Human Research board approved protocol 80 patients with a suspected myocardial ischemic disease recruited from the cardiac cath laboratory will be recruited in this prospective study. Volunteers will be recruited for the purpose of protocol development and will not be included in analysis. All subjects will be screened for glomerular filtration rate (GFR) within 24 hours before the exam. All patients must have a GFR > 30 mL/min/1.73m2 to be part of the study.
- All subjects will be selected following the Nephrogenic Systemic Fibrosis (NSF) guidelines. All dialysis patients or end-stage renal disease patients with a creatinine clearance of < 30 mL/min will not be selected for the study to avoid NSF. Patients with GFR < 60 ml/min but >30 ml/min will receive a reduced dose of Gadolinium contrast (0.1 ml/kg).
You may not qualify if…
- Age <18 years;
- Known contraindication to MR imaging (such as pacemaker placement, magnetic implants, etc);
- Claustrophobia;
- Inability to perform an adequate breath-hold for imaging,
- Inability to provide informed consent;
- all subjects will be will be screened for GFR within 24 hours before the exam and subjects presenting with GFR < 30 ml/min will be excluded;
- Pregnant and lactating women;
- Patients with hypersensitivity to gadolinium contrast agents, metoprolol, adenosine, or nitroglycerin;
- Contra indication for Adenosine
- 2nd- or 3rd-degree atrioventricular block (except in patients with a functioning artificial pacemaker)
- Sinus node disease (except in patients with a functioning artificial
- pacemaker)
- Unstable angina
- Acute myocardial infarction
- Known or suspected bronchoconstrictive or bronchospastic lung
- disease (e.g., asthma)
- Hypersensitivity to adenosine
- Caffeine within 12-24 hours
- Theophylline and Dipyridamole products within 24 hours.
- Contra indication for Metoprolol
- sinus bradycardia
- heart block greater than first degree
- Cardiac Failure
- Bronchospastic Disease
- Contra indication for Nitroglycerin
Where it is running
- Northwestern University — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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