Examining the Genetic Predictors of Coronary Artery Calcification in African Americans

Atherosclerosis Clinical Trial

Official title:

Predictors of Coronary Artery Calcification in an African American Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925561
• Other study ID #: 643
• Secondary ID: R01HL0855715R01H
• Status: Completed
• Phase: N/A
• First received: June 19, 2009
• Last updated: June 18, 2013
• Start date: January 2009
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

Coronary artery disease (CAD) is an important health concern for African Americans, who are diagnosed with CAD at high rates. Coronary artery calcification, which is characterized by calcium deposits in the coronary arteries, is a contributing factor to CAD. This study will examine the possible genetic causes of coronary artery calcification in African Americans.

Description:

In the United States, more people die from CAD than any other disease, with African Americans, particularly women and young men, being more affected by CAD than European Americans. One cause of CAD is atherosclerosis, a condition in which deposits of fat, cholesterol, and other substances build up along the inner walls of arteries. Coronary artery calcification occurs as a result of atherosclerosis and is characterized by calcium build up in the arteries. Non-invasive imaging, including computed tomography (CT) scans, of coronary artery calcification is an effective way to assess CAD risk. The Genetic Epidemiology Network of Arteriopathy (GENOA) study, which is part of the Family Blood Pressure Program (FBPP), is a study that examined siblings with high blood pressure during two exams conducted between 1995 and 2004. The purpose of this new GENOA study, which will enroll past GENOA participants, is to identify genetic factors that may lead to the development of coronary artery calcification in African Americans. Conducting genetic studies in the African American population will result in greater understanding of the mechanisms of atherosclerosis, and may lead to improved strategies for the early identification of people at risk for CAD and the development of new treatments for CAD.

This study will enroll people who have participated in the second GENOA exam and who live in Jackson, Mississippi. Participants will attend one study visit at the University of Mississippi Medical Center. During the study visit, participants will be interviewed by study staff about their medical and family health history; health behaviors; physical activity levels; and use of tobacco, alcohol, and medications. They will complete a walking activity and tasks to assess memory, thinking speed, and accuracy. Participants will also complete a questionnaire about their mood, a physical examination, a CT scan of the heart, and a blood collection. A portion of blood will be stored for future research studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 752
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Participated in the second GENOA exam in Jackson, Mississippi and is alive and willing to participate

Exclusion Criteria:

• Reported a history of heart attack, stroke, or coronary or non-coronary heart surgery

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Calcinosis
• Coronary Artery Disease

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (5)

Lead Sponsor	Collaborator
University of Michigan	Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI), University of Mississippi Medical Center, Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Artery Calcification		Measured during participants' single study visit	No