Hispanic Community Health Study / Study of Latinos

Cardiovascular Disease Clinical Trial

— HCHS/SOL  

Official title:

Hispanic Community Health Study / Study of Latinos (HCHS/SOL)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02060344
• Other study ID #: HCHS-SOL
• Secondary ID: HHSN268201300001
• Status: Active, not recruiting
• Start date: January 2006
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Hispanic Community Health Study / Study of Latinos (HCHS/SOL) is a multi-center epidemiologic study in Hispanic/Latino populations to determine the role of acculturation in the prevalence and development of disease, and to identify risk factors playing a protective or harmful role in Hispanics/Latinos.

Description:

Study goals include studying the prevalence and development of disease in Hispanics/Latinos, the role of acculturation, and to identify risk factors that play protective or harmful roles in Hispanics/Latinos. The target population of 16,000 persons of Hispanic/Latino origin, specifically Cuban, Puerto Rican, Mexican, and Central/South American, to be recruited through four Field Centers affiliated with San Diego State University, Northwestern University in Chicago, Albert Einstein College of Medicine in the Bronx area of New York, and the University of Miami. Seven additional academic centers serve as scientific and logistical support centers. Study participants aged 18-74 years underwent an extensive clinic exam and assessments to determine baseline risk factors. Annual follow-up interviews will be conducted for 2-4 years to determine health outcomes of interest. Study results will be disseminated through scientific journals and also conveyed to the communities involved in the study in order to improve public health at the local level. Annual follow-up interviews will be conducted for 2-4 years to determine health outcomes of interest. Study results will be disseminated through scientific journals and also conveyed to the communities involved in the study in order to improve public health at the local level.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16400
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Hispanic/Latino persons living in the US, aged 18-74 in four communities: San Diego, Bronx NY, Chicago, and Miami.Examination of the cohort following a standardized protocol

Exclusion Criteria:

• Plans to move from the region within 6 months.
• Unable to complete the study questionnaires in English or Spanish.
• Women who are pregnant.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sorlie PD, Aviles-Santa LM, Wassertheil-Smoller S, Kaplan RC, Daviglus ML, Giachello AL, Schneiderman N, Raij L, Talavera G, Allison M, Lavange L, Chambless LE, Heiss G. Design and implementation of the Hispanic Community Health Study/Study of Latinos. Ann Epidemiol. 2010 Aug;20(8):629-41. doi: 10.1016/j.annepidem.2010.03.015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of cardiovascular and pulmonary disease risk factors in Hispanics/Latinos	This is a population-based cohort study of 16,400 Hispanic/Latinos. Objectives: Examination of the cohort following a standardized protocol; Follow-up of the cohort to assess vital status, changes in health status, medication intake, and new cardiovascular and pulmonary events (fatal and non-fatal MI, heart failure, stroke, asthma, and COPD.; Understand the relationship between changes in risk factors and protective factors and onset of CV and pulmonary disease progression; Understand the relationship between changes in sociocultural factors and changes in health; Understand the relationship between baseline CV risk profile of women of childbearing age and incidence of select pregnancy complications	Visit 2 data collection through 2019, preliminary and final analyses through 2019, Annual Follow-up through 2019

External Links

•   HCHS/SOL