Environmental and Genetic Factors That Influence Cardiovascular Disease in African Americans
Recruitment status was Recruiting
|First Received Date ICMJE||May 25, 2000|
|Last Updated Date||April 27, 2006|
|Start Date ICMJE||October 1996|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00005485 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Environmental and Genetic Factors That Influence Cardiovascular Disease in African Americans|
|Official Title ICMJE||Jackson Heart Study (JHS)|
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 an expansion of the Jackson, Mississippi site of the Atherosclerosis Risk in Communities (ARIC) study and is a partnership among two minority institutions (Jackson State University and Tougaloo College), one majority institution in Jackson, Mississippi (the University of Mississippi Medical Center), the National Institutes of Health (NIH) National Center on Minority Health and Health Disparities (NCMHD), and the National Heart, Lung, and Blood Institute (NHLBI).
Heart disease and stroke remain the first and third leading killers of all Americans, with a disproportionate share of the burden borne by African Americans. Cardiovascular and total mortality are known to be higher among African Americans than among white Americans, but reasons for these differences remain unknown. In addition, well-documented declines in CVD and coronary disease mortality in the past three decades have not been shared equally between blacks and whites. Age-adjusted death rates were identical in both groups in 1980, but by 1994 the rate among African Americans was 14% higher than in whites. The race difference in magnitude of coronary heart disease (CHD) mortality is greater in women than men and higher in middle age, such that CHD deaths tend to occur in blacks about 5 years earlier than in whites. Excess cerebrovascular disease incidence and mortality in blacks are even greater than the differences noted in CHD.
Cardiovascular mortality rates in Mississippi, which are approximately 25% higher than the United States average, are the highest in the United States for all race-sex groups. Age-adjusted CVD mortality for African American women in Mississippi was 75% higher than in white women in 1994. The mortality for African American men was 47% higher than in white men.
Prevalence of hypertension is nearly 40% greater in African Americans than in whites and its sequelae are more frequent and severe. Evidence of target organ damage such as renal failure and left ventricular hypertrophy is more common in black than white hypertensives at comparable levels of blood pressure. Many risk factors are also more common in blacks, including diabetes, high serum lipoprotein levels [Lp(a)], and obesity (in women). Other risk factors, such as elevated total cholesterol, reduced high-density lipoprotein (HDL)-cholesterol, and heavy cigarette smoking, are more common in whites.
The Jackson Heart Study (JHS) initial examination, which began in the fall of 2000, included men and women ages 35 to 84, and took 3 years to complete. The coordinating center, located at Jackson State University, collects and analyzes data. The undergraduate training center at Tougaloo College offers coursework to students in public health and epidemiology, and provides practical experience in health research to prepare them for potential careers in these fields. The exam center at the University of Mississippi is responsible for recruiting participants and conducting examinations. JHS is uniquely positioned to answer key questions regarding the excess burden of CVD among African Americans and to address the critical shortage of minority investigators trained in epidemiology and prevention. These questions will be answered by incorporating state-of-the-art physiologic and epidemiologic methods in a stable population-based minority cohort, providing research experience, and building research capabilities at minority institutions. The Second Exam began in September 2005.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||5307|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||35 Years to 84 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00005485|
|Other Study ID Numbers ICMJE||5001, N01 HC95170, N01 HC95171, N01 HC95172|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Heart, Lung, and Blood Institute (NHLBI)|
|Collaborators ICMJE||National Center on Minority Health and Health Disparities (NCMHD)|
|Information Provided By||National Heart, Lung, and Blood Institute (NHLBI)|
|Verification Date||April 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP