MRI Evaluation of Chest Pain

NCT00001961 | Completed Phase 2

• 2 other identifiers: 00002500-H-0025
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain; Coronary Disease; Myocardial Infarction

Keywords

Myocardial Infarction; Coronary Artery Disease; Adenosine; Stress Testing; Perfusion

Interventions

MRI PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• minutes of chest pain compatible with myocardial ischemia (chest pain score greater than 4).
• Less than 270 pounds.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 2816964 BACKGROUND

• 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.

  PMID: 2816965 BACKGROUND

• 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.

  PMID: 8998090 BACKGROUND

MeSH Terms

Conditions

Chest Pain; Coronary Disease; Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 18, 2000
• First Posted: January 19, 2000
• Study Start: December 1, 1999
• Study Completion: January 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2005-01

Locations

US (1)