Coronary Artery DiseaseCoffee&HeartNCT01003392
Influence of Coffee on the Health and on the Heart of Normal, Diabetics e Coronary Artery Disease Patients
An observational study of Coronary Artery Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group of normal patients, group of patients with diagnosed coronary artery disease and group of diabetic patients.
Who may be able to join
- Normal Volunteers:
- Healthy volunteer.
- Age between 20 and 80 years.
- No addict to drugs.
- Absence of chronicle diseases.
- No alcohol abuse.
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- 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:
- Presence of type II Diabetes on oral treatment.
- Age between 20 and 80 years.
- Absence of chronicle diseases, except diabetes.
- No alcohol abuse.
- No smoker.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute (InCor), Univ. of Sao Paulo Medical School
São Paulo, São Paulo, 05403000
Luiz A Machado Cesar, Phd, MD, 551130695387, luiz.cesar@incor.usp.br
Bruno M Mioto, MD, 551130695437, brunomioto@gmail.com
About this study
Official title: Study of Coffee and Its Influence on the Heart in Normal People, Those With Coronary Artery Disease and Diabetics.
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Coffee, Heart system
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal | Normal volunteers, with no diagnosed chronic disease. | |
| Coronary artery disease | Group of patients with diagnosed coronary artery disease. | |
| Diabetes | Diabetic patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality
Measured: 10 years of follow-up
Secondary outcomes (1)
Relationship between coffee ingestion and cardiovascular risk factors
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startMar 2008
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Feculdade de Medicina da Universidade de Sao Paulo - Brasil
- Responsible party
- Principal investigator, Luiz Antonio M. Cesar, University of Sao Paulo
- Investigators
- Luiz A Machado Cesar, PhD, MD., Study chair, Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003392
- Sponsor's protocol ID
- SDC2500/04/120
- Other IDs
- CAPPesq-879/04
- Acronym
- Coffee&Heart
- Status last verified
- Jan 2014
- First submitted
- 26 Oct 2009
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Coffee and Its Influence on the Heart in Normal People, Those With Coronary Artery Disease and Diabetics.
- ClinicalTrials.gov ID
- NCT01003392
- Acronym / sponsor ID
- Coffee&Heart / SDC2500/04/120
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Coffee, Heart system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Feculdade de Medicina da Universidade de Sao Paulo - Brasil
- Study start
- Mar 2008
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –Normal volunteers, with no diagnosed chronic disease. |
| Coronary artery disease | – | –Group of patients with diagnosed coronary artery disease. |
| Diabetes | – | –Diabetic patients. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group of normal patients, group of patients with diagnosed coronary artery disease and group of diabetic patients.
Key inclusion criteria (20 listed)
- Healthy volunteer.
- Age between 20 and 80 years.
- No addict to drugs.
- Absence of chronicle diseases.
- No alcohol abuse.
Key exclusion criteria (11 listed)
- Any blood test with twice or more the upper limit range.
- Presence of enlarged QRS.
- Any blood test with twice or more the upper limit range even with treatment.
- Presence of enlarged QRS.
- Ventricular dysfunction (EF < 45%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality
Time frame: 10 years of follow-up
1 secondary outcome
Relationship between coffee ingestion and cardiovascular risk factors
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heart Institute (InCor), Univ. of Sao Paulo Medical School
São Paulo, Brazil
Luiz A Machado Cesar, PhD, MD. study chair
Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality (time frame: 10 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2014.