Cardiovascular Diseases Clinical Trial
— ELSA-BrasilOfficial title:
Estudo Longitudinal de Saúde do Adulto
The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) aims to contribute with
relevant information regarding the development and progression of clinical and subclinical
chronic diseases, particularly cardiovascular diseases and diabetes. The investigators
enrolled 15,105 civil servants from predefined universities or research institutes. Baseline
assessment (2008-2010) included detailed interviews and measurements to assess social and
biological determinants of health, as well as various clinical and subclinical conditions
related to diabetes, cardiovascular diseases and mental health. For the ascertainment of
incident events, annual telephone surveillance is being conducted since 2009, and a second
visit of interviews and exams is under way (2012-2014). Long-term biological sample storage
is provided for sera, plasma, urine and DNA. Baseline data is available for analyses, and
collaboration via specific research proposals directed to study investigators is welcome.
This multicenter study is chaired by a steering committee, made up of the coordinators and
vice-coordinators of each of the six centers. No individual center coordinates the study.
The six institutions listed in the contact details all sponsor the study.
| Status | Active, not recruiting |
| Enrollment | 15105 |
| Est. completion date | December 2020 |
| Est. primary completion date | December 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 35 Years to 74 Years |
| Eligibility |
Inclusion Criteria: - age 35-74 years, - active or retired employees of the institutions involved or affiliated institutions. Exclusion Criteria: - current or recent (<4 months prior to the first interview) pregnancy, - intention to quit work at the institution in the near future, - severe cognitive or communication impairment and, - if retired, residence outside each center´s corresponding metropolitan area. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Federal University of Rio Grande do Sul |
Aquino EM, Barreto SM, Bensenor IM, Carvalho MS, Chor D, Duncan BB, Lotufo PA, Mill JG, Molina Mdel C, Mota EL, Passos VM, Schmidt MI, Szklo M. Brazilian Longitudinal Study of Adult Health (ELSA-Brasil): objectives and design. Am J Epidemiol. 2012 Feb 15;175(4):315-24. doi: 10.1093/aje/kwr294. Epub 2012 Jan 10. — View Citation
Schmidt MI, Duncan BB, Mill JG, Lotufo PA, Chor D, Barreto SM, Aquino EM, Passos VM, Matos SM, Molina Mdel C, Carvalho MS, Bensenor IM. Cohort Profile: Longitudinal Study of Adult Health (ELSA-Brasil). Int J Epidemiol. 2015 Feb;44(1):68-75. doi: 10.1093/ije/dyu027. Epub 2014 Feb 27. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diabetes mellitus (Incident cases) | Incident cases | 6 years | No |
| Primary | Myocardial infarction (Incident cases) | Incident cases | 6 years | No |
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