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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00493168
Other study ID # 3434
Secondary ID
Status Completed
Phase N/A
First received June 26, 2007
Last updated May 24, 2013
Start date January 1998
Est. completion date November 2006

Study information

Verified date June 2007
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The first aim of this study is to determine how often unrecognized myocardial infarction occur in patients using a magnetic resonance imaging (MRI) technique (known as delayed enhancement MRI), as compared to the electrocardiogram. The second aim of this study is to determine the severity of coronary heart disease of the patients with unrecognized myocardial infarction. The final aim is to determine how the presence of unrecognized myocardial infarction detected by the MRI affects lifespan.


Description:

Unrecognized myocardial infarction (MI) is known to constitute a substantial portion of lethal coronary heart disease. However, since the diagnosis of unrecognized MI is based on the appearance of incidental Q-waves on 12-lead electrocardiography, the syndrome of unrecognized non-Q-wave MI has not been described. Delayed-enhancement cardiovascular magnetic resonance (DE-CMR) can accurately identify non-Q-wave MI. The aims of this study are three-fold: 1. to determine the prevalence of unrecognized non-Q-wave and Q-wave MI, 2. to define predictors of unrecognized non-Q-wave MI, 3. to determine the prognostic significance of unrecognized non-Q-wave MI.


Recruitment information / eligibility

Status Completed
Enrollment 185
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with suspected coronary artery disease referred for invasive coronary angiography

Exclusion Criteria:

- Clinical history of myocardial infarction

- Percutaneous coronary intervention

- Coronary artery bypass surgery

- Known uncured malignancy

- History of hypertrophic cardiomyopathy, myocarditis, or infiltrative heart disease

- Contraindication of magnetic resonance imaging

Study Design

Time Perspective: Prospective


Locations

Country Name City State
United States Northwestern University Medical School Chicago Illinois
United States Duke Cardiovascular Magnetic Resonance Center Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

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