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

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ClinicalTrials.gov Identifier: NCT02060344
Recruitment Status : Unknown
Verified January 2014 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was:  Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)

Brief 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.

Condition or disease
Cardiovascular Disease

Detailed 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.


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Study Type : Observational
Actual Enrollment : 16400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hispanic Community Health Study / Study of Latinos (HCHS/SOL)
Study Start Date : January 2006
Actual Primary Completion Date : June 2013

Group/Cohort
Hispanic/Latinos residing in the US
The cohort consists of over 16,400 persons of Hispanic/Latino origin, ages 18-74, 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.



Primary Outcome Measures :
  1. Prevalence of cardiovascular and pulmonary disease risk factors in Hispanics/Latinos [ Time Frame: Visit 2 data collection through 2019, preliminary and final analyses through 2019, Annual Follow-up through 2019 ]

    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


Biospecimen Retention:   Samples With DNA
Blood and DNA samples were collected.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The of over 16,400 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060344


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jianwen Cai, PhD University of North Carolina, Chapel Hill
Principal Investigator: Robert Kaplan, PhD Einstein College of Medicine
Principal Investigator: Neil Schneiderman, PhD University of Miami
Principal Investigator: Gregory Talavera, MD, MPH San Diego State University
Principal Investigator: Martha Daviglus, MD, PhD University of Illinois at Chicago
Principal Investigator: Scott Solomon, MD Brigham and Women's Hospital

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: HCHS-SOL
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT02060344     History of Changes
Other Study ID Numbers: HCHS-SOL
HHSN268201300001I ( Other Grant/Funding Number: NHLBI )
HHSN268201300002I ( Other Grant/Funding Number: NHLBI )
HHSN268201300003I ( Other Grant/Funding Number: NHLBI )
HHSN268201300004I ( Other Grant/Funding Number: NHLBI )
HHSN268201300005I ( Other Grant/Funding Number: NHLBI )
HHSN268201300024C ( Other Grant/Funding Number: NHLBI )
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: January 2014

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Cardiovascular Disease
Hispanic
Latinos

Additional relevant MeSH terms:
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Cardiovascular Diseases