Examining the Genetic Predictors of Coronary Artery Calcification in African Americans

This study has been completed.
Sponsor:
Collaborators:
University of Mississippi Medical Center
Wake Forest School of Medicine
Mayo Clinic
Information provided by (Responsible Party):
Patricia Peyser, University of Michigan
ClinicalTrials.gov Identifier:
NCT00925561
First received: June 19, 2009
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Predictors of Coronary Artery Calcification in an African American Cohort

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Coronary Artery Calcification [ Time Frame: Measured during participants' single study visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood to measure risk factors and stored DNA for genetic studies


Enrollment: 752
Study Start Date: January 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will come from Jackson, MS and will include all men and women belonging to sibships that previously participated in the second GENOA exam. The sampling frame includes 1482 African Americans in 627 sibships providing 1552 sibling pairs from Jackson, Mississippi.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925561

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Michigan
University of Mississippi Medical Center
Wake Forest School of Medicine
Mayo Clinic
Investigators
Principal Investigator: Patricia Peyser, Ph.D. University of Michigan
  More Information

No publications provided

Responsible Party: Patricia Peyser, Professor of Epidemiology, University of Michigan
ClinicalTrials.gov Identifier: NCT00925561     History of Changes
Other Study ID Numbers: 643, R01HL085571, 5R01 HL085571
Study First Received: June 19, 2009
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Coronary Artery Calcification

Additional relevant MeSH terms:
Atherosclerosis
Calcinosis
Coronary Artery Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases

ClinicalTrials.gov processed this record on July 24, 2014