Magnetic Resonance Imaging of the Blood Vessels of the Heart

Sponsor

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001638

Collaborator

(none)

2,916

Enrollment

Locations

142.1

Duration (Months)

1458

Patients Per Site

10.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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....

Condition or Disease	Intervention/Treatment	Phase
Heart Disease

Detailed Description

This is a teaching protocol. It is in a format for training physicians in the laboratory in cardiovascular MRI techniques necessary for our research protocols. It helps provide experience necessary to develop and maintain our clinical expertise with cardiovascular MRI methods. It also provides physicians in the region access to this technology.

Study Design

Study Type:

Observational

Actual Enrollment :

2916 participants

Official Title:

Cardiovascular Magnetic Resonance Imaging

Study Start Date :

Sep 29, 1997

Actual Primary Completion Date :

Aug 3, 2009

Actual Study Completion Date :

Aug 3, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

Inclusion Criteria for All Arms of the Protocol

Known or suspected cardiovascular disease.
18 years of age and older.
Able to provide informed consent.

Exclusion Criteria for All Arms of the Protocol:

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

Central nervous system aneurysm clips
Implanted neural stimulator
Implanted cardiac pacemaker or defibrillator
Cochlear implant
Ocular foreign body (e.g. metal shavings)
Implanted insulin pump
Metal shrapnel or bullet.

In addition the following patient groups will be excluded:

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

lactating women unless they are willing to discard breast milk for 24 hours
renal disease (estimated glomerular filtration rate [eGFR] less than 30 ml/min/1.73 m(2) body surface area)

The eGFR will be used to estimate renal function if reported by the laboratory. Otherwise, estimated glomerular filtration rate (eGFR) can be based on the Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects with stable renal function.

This formula is not applicable to patients with acute renal insufficiency:

eGFR (ml/min/l.73 m(2))= 175 x (serum creatinine)-l.l54 x (age)-0.203 x 0.742 (if the subject is female) x 1.212 (if the subject is black)

Additional Exclusion Criteria for Dobutamine MRI

Myocardial infarction within 48 hours.
Uncontrolled heart failure
Severe hypertension (SBP greater than 200, DBP greater than 110)
Atrial fibrillation
Ventricular tachycardia
Frequent PVC's (more than 1 every 10 heart beats or nonsustained ventricular tachycardia (greater than 4)
Patients with narrow angle glaucoma or known or suspected severe bladder outlet obstruction due to prostatic hypertrophy will not receive atropine

Additional Exclusion Criteria for Vasodilator Stress MRI

Myocardial infarction within 48 hours.
Patients that are not considered medically stable by their physician (for example, severe heart failure that makes it difficult to breathe while lying flat or severe problems with heart rhythms).
Patients with 2nd or 3rd degree heart block are excluded from receiving the medicine adenosine (abnormalities that can be seen on your ECG).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Suburban Hospital	Bethesda	Maryland	United States	20814
2	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland	United States	20892