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Magnetic Resonance Imaging of the Blood Vessels of the Heart

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001638
First Posted: November 4, 1999
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  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

Study Type: Observational
Official Title: Cardiovascular Magnetic Resonance Imaging

Resource links provided by NLM:


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

Estimated Enrollment: 99999999
Study Start Date: September 29, 1997
Study Completion Date: August 3, 2009
Primary Completion Date: August 3, 2009 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 not receive 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001638


Locations
United States, Maryland
Suburban Hospital
Bethesda, Maryland, United States, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001638     History of Changes
Other Study ID Numbers: 970204
97-H-0204
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: July 2, 2017
Last Verified: August 4, 2009

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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases