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

This study is currently recruiting participants.
Verified June 2010 by University of Sao Paulo
Sponsor:
Collaborator:
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01003392
First received: October 26, 2009
Last updated: June 25, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Study of Coffee and Its Influence on the Heart in Normal People, Those With Coronary Artery Disease and Diabetics.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality [ Time Frame: 10 years of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between coffee ingestion and cardiovascular risk factors [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples.


Estimated Enrollment: 300
Study Start Date: March 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal
Normal volunteers, with no diagnosed chronic disease.
Coronary artery disease
Group of patients with diagnosed coronary artery disease.
Diabetes
Diabetic patients.

Detailed Description:

Patients will have a wash-out period (21 days) with no coffee or other caffeine-drinks. Then they will be submitted to treadmill test, MAPA, Holter-ECG and vascular reactivity study, biochemical and inflammatory plasma dosages, as basal. Then they will start a period of coffee drinking over 4 weeks; and all exams will be repeated. We will study two types of coffee, arabica and robusta; with two types of toasted beans(regular and soft). Also regular and decaffeinated coffee. A total of 300 (100 normal people, 100 diabetics, 100 coronary disease) individuals will be tested.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

Normal Volunteers:

  1. Healthy volunteer.
  2. Age between 20 and 80 years.
  3. No addict to drugs.
  4. Absence of chronicle diseases.
  5. No alcohol abuse.
  6. No smoker.

Coronary artery disease:

  1. Presence of coronary artery disease, by coronary angiography
  2. Stable angina, class 1-3 of CCS.
  3. Age between 20 and 80 years.
  4. Treadmill effort test with ischemia.
  5. No alcohol abuse.
  6. No smoker.

Diabetes:

  1. Presence of type II Diabetes on oral treatment.
  2. Age between 20 and 80 years.
  3. Absence of chronicle diseases, except diabetes.
  4. No alcohol abuse.
  5. No smoker.

Exclusion Criteria:

Normal Volunteers:

  1. Any blood test with twice or more the upper limit range.
  2. Presence of enlarged QRS.

Coronary artery disease:

  1. Any blood test with twice or more the upper limit range even with treatment.
  2. Presence of enlarged QRS.
  3. Ventricular dysfunction (EF < 45%).

Diabetes:

  1. Blood glucose greater than 160 mg/dL.
  2. Others blood tests with twice or more the upper limit range even with treatment.
  3. Presence of enlarged QRS.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003392

Locations
Brazil
Heart Institute (InCor), Univ. of Sao Paulo Medical School Recruiting
Sao Paulo, Brazil, 05403000
Contact: Luiz A Machado Cesar, Phd, MD     551130695387     dcllucesar@incor.usp.br    
Contact: Bruno M Mioto, MD     551130695437     brunomioto@gmail.com    
Sub-Investigator: Bruno M Mioto, MD            
Principal Investigator: Miguel A Moretti, MD, PhD            
Sub-Investigator: Daniela Taratsouchi, nutricionist            
Sub-Investigator: Reynaldo V Amato, MD, PhD            
Sub-Investigator: Vera Lucia Tuda, Nurse            
Sponsors and Collaborators
University of Sao Paulo
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
Investigators
Study Chair: Luiz A Machado Cesar, PhD, MD. Heart Institute
  More Information

No publications provided

Responsible Party: Luiz Antonio Machado Cesar, Heart Institute
ClinicalTrials.gov Identifier: NCT01003392     History of Changes
Other Study ID Numbers: SDC2500/04/120, CAPPesq-879/04
Study First Received: October 26, 2009
Last Updated: June 25, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Coronary artery disease
Coffee
Heart system

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013