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MRI Evaluation of Chest Pain

Primary Purpose

Chest Pain, Coronary Disease, Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Pain focused on measuring Myocardial Infarction, Coronary Artery Disease, Adenosine, Stress Testing, Perfusion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • National Heart, Lung and Blood Institute (NHLBI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 18, 2000
Last Updated
March 3, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001961
Brief Title
MRI Evaluation of Chest Pain
Official Title
MRI Evaluation of Chest Pain Compatible With Myocardial Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2005
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Coronary Disease, Myocardial Infarction
Keywords
Myocardial Infarction, Coronary Artery Disease, Adenosine, Stress Testing, Perfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
360 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
MRI

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
National Heart, Lung and Blood Institute (NHLBI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2816964
Citation
Selker HP. Coronary care unit triage decision aids: how do we know when they work? Am J Med. 1989 Nov;87(5):491-3. doi: 10.1016/s0002-9343(89)80602-3. No abstract available.
Results Reference
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PubMed Identifier
2816965
Citation
Weingarten SR, Ermann B, Riedinger MS, Shah PK, Ellrodt AG. Selecting the best triage rule for patients hospitalized with chest pain. Am J Med. 1989 Nov;87(5):494-500. doi: 10.1016/s0002-9343(89)80603-5.
Results Reference
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PubMed Identifier
8998090
Citation
Tatum JL, Jesse RL, Kontos MC, Nicholson CS, Schmidt KL, Roberts CS, Ornato JP. Comprehensive strategy for the evaluation and triage of the chest pain patient. Ann Emerg Med. 1997 Jan;29(1):116-25. doi: 10.1016/s0196-0644(97)70317-2.
Results Reference
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MRI Evaluation of Chest Pain

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