MRI Evaluation of Chest Pain

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001961
First received: January 18, 2000
Last updated: March 3, 2008
Last verified: January 2005
  Purpose

This study will assess the value of magnetic resonance imaging (MRI) in detecting heart attack and heart attack risk in patients who come to the hospital emergency room because of chest pain. It will also investigate whether MRI can help predict the coronary status of patients 4 to 6 weeks and 1 year after emergency room admission.

Patients who come to the emergency room of Suburban Hospital in Bethesda, MD, because of chest pain may be asked to enroll in this study if they have not been diagnosed as having a heart attack. Participating patients will undergo a MRI scan as soon as emergency room doctors determine they are in stable condition. For this procedure, the patient lies on a table that slides into the MRI scanner-a large tubular machine with a magnetic field. During the scan, a contrast material is injected into the vein. This material brightens the image of the heart so that the blood flow can be seen. The scan will show if there are areas of heart muscle that received insufficient blood flow. A second scan will be done within 72 hours to look for coronary artery blockage that may require treatment. Patients will be followed by telephone 4 to 8 weeks after the scans and again 1 year after the scans to ask about any significant medical problems that may have occurred during those time periods.

This study will provide information that may improve emergency treatment of patients with acute chest pain by clarifying which patients require immediate medical treatment, which should be admitted to the hospital for further evaluation, and which may safely be discharged from the hospital.


Condition Intervention Phase
Chest Pain
Coronary Disease
Myocardial Infarction
Procedure: MRI
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: MRI Evaluation of Chest Pain Compatible With Myocardial Ischemia

Resource links provided by NLM:


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

Estimated Enrollment: 360
Study Start Date: December 1999
Estimated Study Completion Date: January 2005
Detailed Description:

Coronary artery disease remains the leading cause of death in the United States and results in high diagnostic and therapeutic costs. The overall costs associated with the care of patients with cardiovascular disease is projected to be $286.5 billion. Although MRI is a relatively expensive technology, this methodology can provide all the noninvasive diagnostic testing necessary to evaluate and triage patients with coronary artery disease. This "one stop shop" has the potential to lower overall testing on this important patient population and better delineate which patients require intervention. Beyond reproducing the results of existing diagnostic tests, MRI has unique abilities to characterize myocardial tissue adding information in the assessment of these patients that is not attainable by currently available methodologies. This study will examine the hypothesis that MRI assessment of regional LV function, resting myocardial perfusion, and myocardial tissue characteristics can accurately detect a higher fraction of patients with acute myocardial infarction than is possible with the ECG performed in the emergency department.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

Ages above age 21 (children are excluded because myocardial infarction is so rare in this population that the pre-test probability is comparable to the patients with less than 30 minutes of symptoms. Both of these groups have too small a fraction of true positive events to benefit from testing with a sensitivity and specificity of approximately 0.85. If initial results are better, we will reexamine the suitability of these tests for low risk populations).

Capable of giving informed consent.

30 minutes of chest pain compatible with myocardial ischemia (chest pain score greater than 4).

Less than 270 pounds.

EXCLUSION CRITERIA:

Medical exclusions:

Patient states she may be pregnant (confirmed by urine or blood testing).

Severe congestive heart failure (unable to lie flat in bed).

Subjects on a mechanical ventilator.

MRI exclusions:

Subjects with a cardiac pacemaker or implantable defibrillator.

Subjects with a cerebral aneurysm clip.

Subjects with a neural stimulator (e.g. TENS-Unit).

Subjects with any type of ear implant.

Subjects with metal in eye (e.g. from machining).

Subjects with implanted devices (e.g. insulin pump, drug infusion device).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001961

Locations
United States, Maryland
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001961     History of Changes
Other Study ID Numbers: 000025, 00-H-0025
Study First Received: January 18, 2000
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Myocardial Infarction
Coronary Artery Disease
Adenosine
Stress Testing
Perfusion

Additional relevant MeSH terms:
Chest Pain
Myocardial Ischemia
Coronary Disease
Coronary Artery Disease
Infarction
Myocardial Infarction
Pain
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on April 17, 2014