Overview

Comprehensive Evaluation of Ischemic Heart Disease Using MRI

Status:
Completed

Trial end date:
2012-01-01

Target enrollment:
0

Participant gender:
All

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 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.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Northwestern University

Collaborators:

Astellas Pharma US, Inc.
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Treatments:

Adenosine

Criteria

Inclusion Criteria:

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 Criteria:

1. Age <18 years;

2. Known contraindication to MR imaging (such as pacemaker placement, magnetic implants,
etc);

3. Claustrophobia;

4. Inability to perform an adequate breath-hold for imaging,

5. Inability to provide informed consent;

6. 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;

7. Pregnant and lactating women;

8. Patients with hypersensitivity to gadolinium contrast agents, metoprolol, adenosine,
or nitroglycerin;

9. Contra indication for Adenosine

1. 2nd- or 3rd-degree atrioventricular block (except in patients with a functioning
artificial pacemaker)

2. Sinus node disease (except in patients with a functioning artificial

pacemaker)

3. Unstable angina

4. Acute myocardial infarction

5. Known or suspected bronchoconstrictive or bronchospastic lung

disease (e.g., asthma)

6. Hypersensitivity to adenosine

7. Caffeine within 12-24 hours

8. Theophylline and Dipyridamole products within 24 hours.

10. Contra indication for Metoprolol

1. sinus bradycardia

2. heart block greater than first degree

3. Cardiac Failure

4. Bronchospastic Disease

11. Contra indication for Nitroglycerin

1. 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.