Influence of Coffee on the Health and on the Heart of Normal, Diabetics e Coronary Artery Disease Patients

NCT01003392 | Unknown DMC

• 2 other identifiers: SDC2500/04/120CAPPesq-879/04
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Coffee is a worldwide drink, been part of any culture. There are some concerns about effects of coffee on the health. Recently, epidemiological studies have shown benefits of coffee drinking to diabetics and also to prevent diabetes in populations. We aim to understand some effects of coffee and not only caffeine over vascular system, in special coronary artery disease patients, diabetics end normal people.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Coffee; Heart system

Outcome Measures

Primary Outcomes (1)

• Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality

  10 years of follow-up

Secondary Outcomes (1)

• Relationship between coffee ingestion and cardiovascular risk factors

  10 years

Study Arms (3)

Normal

Normal volunteers, with no diagnosed chronic disease.

Coronary artery disease

Group of patients with diagnosed coronary artery disease.

Diabetes

Diabetic patients.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group of normal patients, group of patients with diagnosed coronary artery disease and group of diabetic patients.

You may qualify if:

• Normal Volunteers:
• Healthy volunteer.
• Age between 20 and 80 years.
• No addict to drugs.
• Absence of chronicle diseases.
• No alcohol abuse.
• No smoker.
• Coronary artery disease:
• Presence of coronary artery disease, by coronary angiography
• Stable angina, class 1-3 of CCS.
• Age between 20 and 80 years.
• Treadmill effort test with ischemia.
• No alcohol abuse.
• No smoker.
• Diabetes:

You may not qualify if:

• Normal Volunteers:
• Any blood test with twice or more the upper limit range.
• Presence of enlarged QRS.
• Coronary artery disease:
• Any blood test with twice or more the upper limit range even with treatment.
• Presence of enlarged QRS.
• Ventricular dysfunction (EF \< 45%).
• Diabetes:
• Blood glucose greater than 160 mg/dL.
• Others blood tests with twice or more the upper limit range even with treatment.
• Presence of enlarged QRS.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Feculdade de Medicina da Universidade de Sao Paulo - Brasil: collaborator

Study Sites (1)

Heart Institute (InCor), Univ. of Sao Paulo Medical School

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Luiz A Machado Cesar, PhD, MD.

  Heart Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: October 28, 2009
• Study Start: March 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

BR (1)