Status:
COMPLETED
Comprehensive Evaluation of Ischemic Heart Disease Using MRI
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Astellas Pharma US, Inc.
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Conditions:
Heart Disease, Ischemic
Atherosclerosis, Coronary
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 myocard...
Detailed Description
Coronary heart disease is the leading cause of death and disability in the US, accounting for about one-third of all deaths in subjects over age 35. With the development of newer Magnetic Resonance I...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
- Early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin.
- b .Administration of Nitrostat (nitroglycerin tablets, USP) is contraindicated in patients who are using Viagra® since Viagra has been shown to potentiate the hypotensive effects of organic nitrates.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01234870
Start Date
June 1 2010
End Date
January 1 2012
Last Update
September 26 2014
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611