Completed

MRI Evaluation of Chest Pain Compatible With Myocardial Ischemia

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What is being tested

MRI

Procedure
Who is being recruted

Arterial Occlusive Diseases+15

+ Arteriosclerosis

+ Cardiovascular Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 1999
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00001961
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

360 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesHeart DiseasesInfarctionIschemiaNecrosisNeurologic ManifestationsPainPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaChest PainCoronary Artery DiseaseCoronary DiseaseMyocardial Infarction

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).

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, United StatesOpen National Heart, Lung and Blood Institute (NHLBI) in Google Maps
CompletedOne Study Center