Genomic Approaches to Common Chronic Disease - Ancillary to ARIC

Cardiovascular Disease Clinical Trial

Official title:

Genomic Approaches to Common Chronic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808353
• Other study ID #: CFDA No: 93.859
• Secondary ID: 5P50GM065509
• Status: Completed
• Phase: N/A
• First received: December 12, 2008
• Last updated: December 12, 2008
• Start date: July 1985

Study information

• Verified date: December 2008
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The ARIC study is a prospective epidemiologic study conducted in four U.S. communities and designed to investigate the etiology and natural history of atherosclerosis, the etiology of clinical atherosclerotic diseases, and variation in cardiovascular risk factors, medical care and disease by race, gender, location, and date.

Description:

The Atherosclerosis Risk in Communities Study (ARIC), sponsored by the National Heart, Lung and Blood Institute (NHLBI), is a prospective epidemiologic study conducted in four U.S. communities. ARIC is designed to investigate the etiology and natural history of atherosclerosis, the etiology of clinical atherosclerotic diseases, and variation in cardiovascular risk factors, medical care and disease by race, gender, location, and date.

ARIC includes two parts: the Cohort Component and the Community Surveillance Component. The Cohort Component began in 1987, and each ARIC field center randomly selected and recruited a cohort sample of approximately 4,000 individuals aged 45-64 from a defined population in their community. A total of 15,792 participants received an extensive examination, including medical, social, and demographic data. These participants were reexamined every three years with the first screen (baseline) occurring in 1987-89, the second in 1990-92, the third in 1993-95, and the fourth and last exam was in 1996-98. Follow-up occurs yearly by telephone to maintain contact with participants and to assess health status of the cohort.

In the Community Surveillance Component, currently ongoing, these four communities are investigated to determine the community-wide occurrence of hospitalized myocardial infarction and coronary heart disease deaths in men and women aged 35-84 years. Hospitalized stroke is investigated in cohort participants only. The study conducts community surveillance of inpatient heart failure (ages 55 years and older) and cohort surveillance outpatient heart failure events beginning in 2005.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15792
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 64 Years

Eligibility

Inclusion Criteria:

• The ARIC study began in 1987, and each ARIC field center randomly selected and recruited a cohort sample of approximately 4,000 individuals aged 45-64 from a defined population in their community

Exclusion Criteria:

• Those not meeting the inclusion criteria

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Disease

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of Michigan	Baylor College of Medicine, Cornell University, University of Texas, Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular disease and its risk factors		One year	No
Secondary	Additional common chronic disease risk factors		One year	No