Status:
COMPLETED
Brazilian Heart-Prevent Meal - A Pilot Randomized Clinical Trial
Lead Sponsor:
Hospital do Coracao
Collaborating Sponsors:
Ministry of Health, Brazil
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effectiveness of a brazilian cardioprotective diet plan to reduce cardiovascular risk factors of new cardiovascular events.
Detailed Description
Cardiovascular diseases are the leading cause of mortality in both sexes in Brazil and worldwide. Modifying risk factors such as diet and lifestyle can prevent most cases of cardiovascular disease. Th...
Eligibility Criteria
Inclusion
- Any coronary artery disease evidence in the past 10 years; or any ischemic stroke or TIA evidence in the past 10 years; or peripheral arterial disease in the past 10 years; or at least one of the following additional risk factors:
- Diabetes Mellitus; Hypertension; Dyslipidemia; Coronary artery disease family history;
- Asymptomatic carotid artery disease;
- Body mass index\> 25 kg/m2 for adults and\> 28 kg/m2 for seniors
Exclusion
- Neurocognitive or psychiatric condition;
- Life expectancy less than 6 months (eg, metastatic malignancy or other defined as clinical trial investigators).
- Pregnancy or breast feeding.
- Hepatic impairment defined as elevated liver enzymes above three times the upper limit of normal
- Renal impairment defined as creatinine values higher than 1.5 mg/dL.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01453166
Start Date
September 1 2011
End Date
January 1 2012
Last Update
July 19 2012
Active Locations (1)
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1
Hospital do Coracao
São Paulo, São Paulo, Brazil, 04005000