Cardiovascular Diseases Clinical Trial
Official title:
Incidence of Diabetes and Cardiovascular Disease in Mexican Americans
To determine the incidence of type II diabetes and cardiovascular disease among Mexican-American and non-Hispanic whites in a 15 to 24 year follow-up of the San Antonio Heart Study 1 participants. Also, to perform a 15 to 24 year mortality follow-up of the cohort and to examine the "Hispanic paradox".
BACKGROUND:
The San Antonio Heart Study 1 was a population-based survey of diabetes and cardiovascular
risk factors in Mexican Americans and non-Hispanic whites conducted from 1979 to 1982.
Participants included all men and non-pregnant women ages 24 to 64, who resided in
households randomly sampled from three socio-culturally distinct neighborhoods of San
Antonio. The low-income barrio residents were almost exclusively traditional
Mexican-Americans. The middle-income neighborhood was ethnically balanced with equal numbers
of Mexican Americans and Anglos whereas the upper income suburb was approximately 90 percent
Anglo. Risk factors measured included obesity, glucose intolerance, hypertriglyceridemia,
low levels of high density lipoprotein cholesterol, and blood pressure. The total number of
people who were examined medically was 2,386, divided as follows: 1,288 Mexican Americans;
929 Anglos; and 169 other Hispanics such as Cubans. The San Antonio Heart Study 1 was
designed to test the hypothesis that as Mexican Americans became progressively more affluent
and accultured to mainstream United States culture, they would gradually lose their diabetic
pattern of cardiovascular risk factors of obesity, diabetes, and hypertriglyceridemia.
Mexican Americans are the second largest minority group in the United States. Despite this,
as recently as 1977, little was known about their health status. In recent years this
situation has begun to change with publication of results from several major studies
including the San Antonio Heart Study, the Starr County Study, and most recently the
Hispanic Health and Nutrition Examination Survey (HHANES).
DESIGN NARRATIVE:
Beginning in 1987, each participant in the prospective San Antonio Heart Study 1 was
recalled as close as possible to the eighth anniversary of his or her baseline examination
and re-examined. Subjects had fasting lipid and lipoprotein determinations, a glucose
tolerance test to diagnose incident cases of non-insulin dependent diabetes mellitus
according to the National Diabetes Data Group criteria, blood pressure measurements, a
resting electrocardiogram, and completed a questionnaire to elicit information on possible
cardiovascular endpoints. Medical records were obtained to document the endpoints. Subjects
with a history of peripheral vascular disease or diabetes had ankle/arm blood pressure
ratios determined before and after exercise. Deaths were ascertained in the course of
routine follow-up supplemented by search of state health department and National Death Index
records. Death certificates were requested and for those certificates indicating diabetes or
cardiovascular disease as the cause of death, hospital or physician records were requested
and reviewed. Standardized criteria were used to validate cause of death. Endpoints included
diabetes, sudden cardiac death, non-fatal (including silent) myocardial infarction, angina
pectoris, cerebrovascular and peripheral vascular disease. The study was renewed in 1992 to
continue follow-up.
The study was renewed in 1998 to perform a 15 to 24 year mortality follow-up of the cohort.
Time dependencies in the ethnic mortality ratio were examined as well as other covariates
such as biochemical parameters, hemodynamic variables, and anthropometric variables such as
socioeconomic status, health care access and utilization and migrant status. A sample of 200
Mexican-American and 200 non-Hispanic white death certificates were verified by medical
record review. The purpose of the review was to determine whether Mexican Americans, deemed
to have died of cardiovascular causes based on medical record review, were more or less
likely to have cardiovascular codes (ICDA 390-459) listed on their death certificates than
non-Hispanic whites deemed to have died of these causes. The review aided in the
interpretation of data relating to possible ethnic differences in cause-specific mortality
based on death certificate coding.
The study should help to explain whether the "Hispanic paradox" is an artifact of
underascertainment of deaths in this group. The "Hispanic paradox" refers to the concept
that all-cause and cardiovascular (CV) mortality are widely thought to be lower in
Hispanics, including Mexican Americans, than in non-Hispanic whites in the United States.
Preliminary mortality data from this study suggest that all-cause mortality is actually
higher in Mexican Americans than in non-Hispanic whites in San Antonio.
;
N/A
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|