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Magnetic Resonance Imaging of the Blood Vessels of the Heart
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), August 2008
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001638
  Purpose

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
Heart Disease

MedlinePlus related topics: Heart Diseases MRI Scans
Drug Information available for: Dobutamine Dobutamine hydrochloride Dobutamine lactobionate Dobutamine tartrate
U.S. FDA Resources
Study Type: Observational
Official Title: Cardiovascular Magnetic Resonance Imaging

Further study details as provided by National Institutes of Health Clinical Center (CC):

Study Start Date: September 1997
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Inclusion Criteria for All Arms of the Protocol

  1. Known or suspected cardiovascular disease.
  2. 18 years of age and older.
  3. 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:

  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. Implanted 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 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 unless they are willing to discard breast milk for 24 hours
  2. 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

  1. Myocardial infarction within 48 hours.
  2. Uncontrolled heart failure
  3. Severe hypertension (SBP greater than 200, DBP greater than 110)
  4. Atrial fibrillation
  5. Ventricular tachycardia
  6. Frequent PVC's (more than 1 every 10 heart beats or nonsustained ventricular tachycardia (greater than 4)
  7. Patients with narrow angle glaucoma or known or suspected severe bladder outlet obstruction due to prostatic hypertrophy will notreceive atropine

Additional Exclusion Criteria for Vasodilator Stress MRI

  1. Myocardial infarction within 48 hours.
  2. 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).
  3. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001638

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 970204, 97-H-0204
Study First Received: November 3, 1999
Last Updated: December 31, 2008
ClinicalTrials.gov Identifier: NCT00001638  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Echocardiography
Heart
Gadolinium
Dobutamine
Toxicity
Adverse Events
Myocardial Infarction
Myocardial Viability
Myocardial Perfusion
Myocardial Function
Cardiovascular Disease

Study placed in the following topic categories:
Heart Diseases
Infarction
Myocardial Infarction
Dobutamine

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009