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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:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • INCLUSION CRITERIA:

Inclusion Criteria for All Arms of the Protocol

  1. Patient's without history of coronary artery disease, who are greater than or equal to 18 years of age, are eligible for a resting MRI scan with contrast.
  2. Patients with known or suspected cardiovascular disease, who are greater than or equal to 18 years of age, will be eligible for participation in the stress portion of this protocol. The exclusion of subjects under the age of 18 is based on the diseases targeted by our technical developments. Coronary artery disease and peripheral vascular disease are rare in subjects less than 18. Thus, it makes no sense to recruit such patients.
  3. Written informed consent.

Additional Inclusion Criteria for Dobutamine or Vasodilator Stress MRI

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

EXCLUSION CRITERIA:

Exclusion Criteria for All Arms of the Protocol

  1. Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
  2. Central nervous system aneurysm clips
  3. Implanted neural stimulator
  4. Implanted cardiac pacemaker or defibrillator
  5. Cochlear implant
  6. Ocular foreign body (e.g. metal shavings)
  7. Insulin pump
  8. 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. renal disease (estimated glomerular filtration rate [eGFR] less than 30 ml/min/1.73m(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 in subjects with stable renal function. This formula is not applicable to patients with acute renal insufficiency:

eGFR (ml/min/1.73 m2) = 175 times (serum creatinine)-1.154 times (age)-0.203 times 0.742 (if the subject is female) times 1.212 (if the subject is black)

Additional Exclusion Criteria for Dobutamine MRI

  1. Myocardial infarction within 48 hours (troponin greater than 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 nonsustained ventricular tachycardia (greater than 4)
  7. Patients with narrow angle glaucoma will not receive atropine

Additional Exclusion Criteria for Vasodilator Stress MRI

  1. Myocardial infarction within 48 hours (troponin greater than 6 ng/ml).
  2. Patients that are not considered medically stable by their physician (for example, severe heart damage 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
First Received:   November 3, 1999
Last Updated:   September 18, 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 November 30, 2008




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