NCT03139071

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

April 26, 2017

Last Update Submit

May 1, 2017

Conditions

Keywords

coffee consumptioncardiovascular diseasescoronary artery calciumsubclinical atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • subclinical atherosclerosis

    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.

Eligibility Criteria

Age35 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dirce Maria Marchioni

São Paulo, São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

AtherosclerosisCardiovascular Diseases

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 3, 2017

Study Start

August 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 3, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations