Protocol Number: 97-H-0204

Title:

Cardiovascular Magnetic Resonance Imaging

Number:

97-H-0204

Summary:

This study is directed at evaluating patients with "myocardial ischemia" or poor blood supply to the heart muscle due to coronary artery disease. The major objective of this study is to determine the level of safety and effectiveness of magnetic resonance imaging at diagnosing coronary artery disease.

In addition, this study will allow researchers at the National Institutes of Health to see a broad spectrum of disease, preserve clinical skills, and stimulate future ideas for clinical research.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA

All Arms:

Patients with known or suspected cardiovascular disease will be eligible for participation in this protocol. The patient is eligible under the following conditions:

1. Patient's age is greater than 21 years of age.

Dobutamine Stress MRI:

1. Known or suspected coronary artery disease or valvular heart disease.

EXCLUSION CRITERIA

All Arms:

Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:

1. Central nervous system aneurysm clips

2. Implanted neural stimulator

3. Implanted cardiac pacemaker or defibrillator

4. Cochlear implant

5. Ocular foreign body (e.g. metal shavings)

6. Insulin pump

7. Metal shrapnel or bullet.

In addition the following patient groups will be excluded:

1. Pregnant women( patients who are uncertain as to whether they are pregnant will be required to have a screening urine or blood pregnancy test).

2. Patients with surgery of uncertain type where the presence of metal clips or wires cannot be excluded.

3. Patients with symptoms of myocardial ischemia occurring despite maximally tolerated doses of oral antianginal therapy and intravenous nitroglycerin.

Furthermore, the following patient groups will be excluded from studies involving the administration of MRI contrast agents:

1. Lactating women

2. Patients with hemoglobinopathies

3. Renal disease (CrCl less than 20 ml/min)

Dobutamine Stress MRI:

1. Myocardial infarction within 48 hours (CKMB greater than 3 times normal limits).

2. Uncontrolled congestive heart failure

3. Severe hypertension (SBP greater than 200, DBP greater than 100).

4. Atrial fibrillation.

5. Ventricular tachycardia.

6. Frequent PVC's (more than 1 every 10 heart beats or sustained ventricular tachycardia (greater than 4)).

7. Patients with narrow angle glaucoma will not receive atropine.

Special Instructions:

The following items may be hazardous: cardiac pacemaker or autodefibrillator, aneurysm clip, neural stimulator (e.g. TENS-Unit), any type of ear implant, metal in your eye (e.g. from machining metal), any implanted device (e.g. insulin pump, drug infusion device), or any metallic foreign body, shrapnel, or bullet.

Keywords:

Echocardiography

Heart

Gadolinium

Dobutamine

Toxicity

Adverse Events

Myocardial Infarction

Myocardial Viability

Myocardial Perfusion

Myocardial Function

Recruitment Keywords:

Cardiovascular Disease

Conditions:

Heart Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Measurement of relative cerebral blood volume changes with visual stimulation by 'double-dose' gadopentate-dimeglumine-enhanced dynamic magnetic resonance imaging

Brain mapping with functional MRI imaging: comparison of gradient-echo-based exogenous and endogenous contrast techniques

Tolerance data of Gd-DTPA: a review

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Bethesda, Maryland 20892. Last update: 10/19/2004