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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005410
Other study ID # 4328
Secondary ID R03HL047208
Status Completed
Phase N/A
First received May 25, 2000
Last updated February 17, 2016
Start date June 1991
Est. completion date May 1993

Study information

Verified date May 2000
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To conduct an analysis of the epidemiology of coronary heart disease (CHD) in Blacks using data collected from the 'Survival and Ventricular Enlargement (SAVE) Following Myocardial Infarction' study.


Description:

BACKGROUND:

Ample data now exist to dispel the prevailing clinical impression that coronary heart disease (CHD) occurs infrequently in United States Blacks. It is well known that CHD is the leading cause of death among United States Blacks. Among patients with acute myocardial infarction who often present with typical ischemic chest pain, it has been shown that Blacks present more often without chest pain when compared to whites and Hispanics. In addition, more than 25 percent of the myocardial infarction patients have unrecognized infarctions. Morbidity and mortality associated with angina pectoris, cardiovascular disease, and myocardial infarction occurs in United States Blacks at rates which are at least comparable to their white counterparts. Yet, there are limited epidemiological studies designed to identify the determinants of CHD in the Black population.

The patients were originally screened to participate in a multicenter clinical trial on 'Survival and Ventricular Enlargement (SAVE) Following Myocardial Infarction.' Only 28 patients out of 599 screened subjects were eligible for the SAVE study. The baseline data obtained from the 599 screened subjects comprised the database.

DESIGN NARRATIVE:

Data analysis was performed to: determine the prevalence of coronary heart disease in Blacks presenting with chest pain; identify the correlates of CHD in Blacks; determine the sensitivity and specificity of a Rose questionnaire angina in Blacks; determine the association between the Rose questionnaire angina and CHD manifestations in Blacks, and identify predictive and causal models of CHD.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date May 1993
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

Adams-Campbell LL, Peniston RL, Kim KS, Mensah E. Body mass index and coronary artery disease in African-Americans. Obes Res. 1995 May;3(3):215-9. — View Citation

Peniston RL, Adams-Campbell L, Fletcher JW, Williams EC, Murigande C, Mensah E, Crittenden MD, Diggs JA. Coronary arteriographic findings in black patients and risk markers for coronary artery disease. Am Heart J. 1994 Mar;127(3):552-9. — View Citation

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