Coffee Consumption and Coronary Artery Calcium Score

May 1, 2017 updated by: Dirce Maria Lobo Marchioni, University of Sao Paulo

Coffee Consumption and Coronary Artery Calcium Score: Results From the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil)

Coffee is one of the dietary factors associated with cardiovascular disease (CVD) but its role in the cardiovascular system is not yet clear. Moreover, available evidence for the relation between coffee intake with subclinical atherosclerosis is limited and inconsistent. The aim of this study was to evaluate the association between habitual coffee consumption and the presence of subclinical atherosclerosis measured as coronary artery calcium (CAC) in the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil). This is a cross-sectional study based on baseline data from participants of the cohort ELSA-Brasil. In this analysis, only participants living in São Paulo with no prior history of CVD aged 35 to 74 years who underwent a CAC measurement (n=4,426) were included. Dietary data were collected using a validated food frequency questionnaire. Coronary calcification was detected with computed tomographic and it was expressed as Agatston units. CAC was further categorized as 0 or >0, and <100 or ≥100.

Study Overview

Status

Completed

Detailed Description

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

Enrollment (Actual)

4426

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • SP
      • São Paulo, SP, Brazil, 01246-000
        • Dirce Maria Marchioni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Longitudinal Study of Adult Health (ELSA-Brasil) is a cohort study that 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.

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. 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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Missing data at baseline for coffee intake, and self-reported history of cardiovascular disease defined as prior myocardial infarction, angina, stroke, heart failure, and coronary revascularization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 2 to 4 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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