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NCT00005485 Clinical Trial

The Jackson Heart Study of Cardiovascular Disease Among African Americans

Hypertension Clinical Trial

— JHS  

Official title:
The Jackson Heart Study of Cardiovascular Disease Among African Americans

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00005485
Other study ID # 5001
Secondary ID HHSN268201800010
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 19, 2000
Est. completion date August 12, 2025

Study information
Verified date April 2024
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective study of the environmental and genetic factors that influence the development of cardiovascular disease (CVD) in African American men and women. The cohort is a collaboration among multiple institutions (Jackson State University, Mississippi State Department of Health, Tougaloo College, and the University of Mississippi Medical Center), the National Institute on Minority Health and Health Disparities (NIMHD), and the National Heart, Lung, and Blood Institute (NHLBI).

Description:

The Jackson Heart Study (JHS) initiated in 1998, is a longitudinal investigation of genetic and environmental risk factors associated with the disproportionate burden of cardiovascular disease (CVD) in African Americans. In addition, the JHS conducts community education and outreach activities to promote healthy lifestyles and reduce disease risk burden, undergraduate- and graduate-level research training programs, and high school science and math enrichment programs to prepare and encourage students from underrepresented racial/ethnic groups to pursue biomedical careers. The study recruited 5306 African-American residents living in the Jackson, MS, metropolitan statistical area of Hinds, Madison, and Rankin Counties. Participants were enrolled from each of 4 recruitment pools: random, 17%; volunteer, 30%; currently enrolled in the Atherosclerosis Risk in Communities (ARIC) Study, 31% (shared JHS/ARIC cohort); and secondary family members, 22%. Recruitment was limited to non-institutionalized adult African Americans aged 35-84 years, except in a nested family cohort where those 21 to 34 years of age were also eligible. The final cohort included 6.59% of all African American residents in the Jackson MSA aged 35-84 during the baseline exam (N=76,426, US Census 2000). Among these, approximately 3,700 gave consent that allows genetic research and deposition of data into dbGaP. JHS participants have completed three clinical examinations (Exam 1, 2000-04; Exam 2, 2005-08; and Exam 3, 2009-13) that have generated extensive longitudinal data on traditional and putative CVD risk factors, socioeconomic and sociocultural factors, biochemical analytes, and measures of subclinical disease from echocardiography, cardiac magnetic resonance imaging (MRI), and computed tomography (CT) scans of the heart, aorta, and abdomen. Stored biological samples have been assayed for putative biochemical risk factors and stored for future research. DNA has been extracted and lymphocytes cryopreserved for study of candidate genes, genome-wide scanning, expression, and other -omics investigations. Participants have been contacted annually to update information, confirm vital status, document interim medical events, hospitalizations, and functional status, and obtain additional sociocultural information. Ongoing cohort surveillance includes abstraction of medical records and death certificates for relevant International Classification of Diseases (ICD) codes and adjudication of nonfatal events and deaths. The JHS serves as a resource to the scientific community for novel research, promotes cardiovascular health in the local community, and encourages underrepresented minority students to pursue biomedical careers. Exam 4 began in 2020 and is ongoing. Data collection for the current exam includes anthropometrics, blood pressure, urine and blood samples, echocardiogram, electrocardiogram, neurocognitive battery, physical function, interviews, and brain MRI.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 3000
Est. completion date August 12, 2025
Est. primary completion date August 12, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 84 Years
Eligibility Inclusion Criteria: - African American - Residents of Jackson, Mississippi Exclusion Criteria: - Institutionalization

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States UMMC, JSU, Tougaloo College, MSDH Jackson Mississippi

Sponsors (2)
Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI) National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Carpenter MA, Crow R, Steffes M, Rock W, Heilbraun J, Evans G, Skelton T, Jensen R, Sarpong D. Laboratory, reading center, and coordinating center data management methods in the Jackson Heart Study. Am J Med Sci. 2004 Sep;328(3):131-44. doi: 10.1097/00000441-200409000-00001. — View Citation

Crook ED, Taylor H. Traditional and non-traditional risk factors for cardiovascular and renal disease in African Americans: a project of the Jackson Heart Study investigators. Am J Med Sci. 2002 Sep;324(3):115. doi: 10.1097/00000441-200209000-00001. No abstract available. — View Citation

Crook ED, Taylor H. Traditional and nontraditional risk factors for cardiovascular and renal disease in African Americans (Part 2): a project of the Jackson Heart Study investigators. Am J Med Sci. 2003 Jun;325(6):305-6. doi: 10.1097/00000441-200306000-00001. No abstract available. — View Citation

Sempos CT, Bild DE, Manolio TA. Overview of the Jackson Heart Study: a study of cardiovascular diseases in African American men and women. Am J Med Sci. 1999 Mar;317(3):142-6. doi: 10.1097/00000441-199903000-00002. — View Citation

Taylor HA Jr, Clark BL, Garrison RJ, Andrew ME, Han H, Fox ER, Arnett DK, Samdarshi T, Jones DW. Relation of aortic valve sclerosis to risk of coronary heart disease in African-Americans. Am J Cardiol. 2005 Feb 1;95(3):401-4. doi: 10.1016/j.amjcard.2004.09.043. — View Citation

Taylor HA Jr. Establishing a foundation for cardiovascular disease research in an African-American community--the Jackson Heart Study. Ethn Dis. 2003 Fall;13(4):411-3. — View Citation

Wyatt SB, Diekelmann N, Henderson F, Andrew ME, Billingsley G, Felder SH, Fuqua S, Jackson PB. A community-driven model of research participation: the Jackson Heart Study Participant Recruitment and Retention Study. Ethn Dis. 2003 Fall;13(4):438-55. — View Citation

Wyatt SB, Williams DR, Calvin R, Henderson FC, Walker ER, Winters K. Racism and cardiovascular disease in African Americans. Am J Med Sci. 2003 Jun;325(6):315-31. doi: 10.1097/00000441-200306000-00003. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiovascular Disease Coronary Heart Disease, Stroke, Heart Failure 2000-2016
Secondary Mortality All Cause 2000-2018
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