Coffee Consumption and Coronary Artery Calcium Score
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|ClinicalTrials.gov Identifier: NCT03139071|
Recruitment Status : Completed
First Posted : May 3, 2017
Last Update Posted : May 3, 2017
|Condition or disease|
|Atherosclerosis Cardiovascular Diseases|
The Longitudinal Study of Adult Health (ELSA-Brasil) is a cohort study designed to identify risk factors for diabetes and CVD. Briefly, the cohort comprises 15,105 civil servants, aged 35 to 74 years at baseline, who were sampled from universities or research institutions located in six cities (Belo Horizonte, Porto Alegre, Rio de Janeiro, Salvador, São Paulo, and Vitoria) of three different regions of Brazil. Baseline assessment was conducted from August 2008 to December 2010 and consisted of an approximately 7-hour evaluation, which included personal interviews conducted by trained personnel. These interviews focused on sociodemographic characteristics, health and medical history, occupational exposure, family history of disease, reproductive health, health care, psychosocial factors, body weight history and body image, food consumption, smoking, alcohol consumption, physical activity, medication use, cognitive function, mental health, and clinical and laboratory measurements. In addition, the participants at the ELSA-Brasil site in São Paulo were invited to perform a computed tomographic (CT) examination to quantify coronary artery calcium (CAC).
Thus, for the current investigation, only participants of the ELSA-Brasil of São Paulo Research Center who submitted to CAC determination (n=4,549) were included. In addition, in the present analysis, we considered individuals without missing data at baseline for coffee intake, and no self-reported history of cardiovascular disease defined as prior myocardial infarction, angina, stroke, heart failure, and coronary revascularization. Therefore, the final study sample comprised 4,426 individuals who submitted to CAC measurements and did not fulfill exclusion criteria to participate in this subset of the study.
The ELSA-Brasil protocol was approved at all six centers by the institutional review boards addressing research in human participants. All the subjects signed a written informed consent form.
|Study Type :||Observational|
|Actual Enrollment :||4426 participants|
|Official Title:||Coffee Consumption and Coronary Artery Calcium Score: Results From the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil)|
|Actual Study Start Date :||August 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
- subclinical atherosclerosis [ Time Frame: Through study completion, an average of 2 to 4 years. ]The presence and severity of subclinical atherosclerosis were measured as coronary artery calcium. The ELSA-Brasil participants from the São Paulo site underwent noncontrast computed tomographic (CT) for CAC score evaluation. The scans were performed using a 64 detector CT scanner (Brilliance 64; Philips Healthcare, Philips Healthcare, Best, Netherlands). The measurement of the CAC score was calculated using a threshold of 130 HU and expressed in Agatston units.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139071
|Dirce Maria Marchioni|
|São Paulo, SP, Brazil, 01246-000|