CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention (CORDIOPREV)
This study is ongoing, but not recruiting participants.
Sponsor:
Hospital Universitario Reina Sofia
Information provided by (Responsible Party):
Francisco Perez Jimenez, Hospital Universitario Reina Sofia
ClinicalTrials.gov Identifier:
NCT00924937
First received: June 18, 2009
Last updated: April 6, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular events of persons with coronary disease.
| Condition | Intervention |
|---|---|
|
Myocardial Infarction Unstable Angina Malignancy Cognitive Decline |
Behavioral: Diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease |
Resource links provided by NLM:
Further study details as provided by Hospital Universitario Reina Sofia:
Primary Outcome Measures:
- Incidence of cardiac death, myocardial infarction, angina event, coronary revascularization or cardiac transplant, stroke, symptomatic heart failure, or any other clinical manifestation of cardiovascular event. [ Time Frame: Five Years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of intermittent claudication. [ Time Frame: Five years ] [ Designated as safety issue: No ]
- Concentration of LDL cholesterol. [ Time Frame: Five years ] [ Designated as safety issue: No ]
- Atherogenic ratio Total cholesterol/HDL and LDL/HDL. [ Time Frame: Five Years ] [ Designated as safety issue: No ]
- Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose). [ Time Frame: Five Years ] [ Designated as safety issue: No ]
- Blood pressure. [ Time Frame: Five Years ] [ Designated as safety issue: No ]
- Response to ergometry tests. [ Time Frame: Five Years ] [ Designated as safety issue: No ]
- Incidence of malignancy. [ Time Frame: Five Years ] [ Designated as safety issue: No ]
- Progression of Cognitive Decline. [ Time Frame: Five Years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 874 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2018 |
| Estimated Primary Completion Date: | November 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Low Fat
Low fat diet: 28% fat (12% MUFA; 8%PUFA; 8% SAT)
|
Behavioral: Diet
Low fat diet: 28% fat (12% MUFA; 8%PUFA; 8% SAT)
Other Name: Dieta Baja en grasas
|
|
Experimental: Mediterranean Diet
Mediterranean Diet: 34% fat (22% MUFA; 6% PUFA; 7% SAT).
|
Behavioral: Diet
Mediterranean Diet: 34% fat (22% MUFA; 6% PUFA; 7% SAT).
Other Name: Dieta Mediterranea
|
Detailed Description:
Randomized clinical trial involving 874 patients with coronary disease that will undergo one of two diets in a randomized design (two groups of 437 patients each) for 5 years. The two diets will be: a)Low fat diet: 28% fat (12% MUFA; 8%PUFA; 8% SAT) and b) Mediterranean Diet: 34% fat (22% MUFA; 6% PUFA; 7% SAT).
Primary Objective: To compare the effects of the two dietary patterns on the incidence of cardiac death, myocardial infarction, angina event, coronary revascularization or cardiac transplant, stroke, symptomatic heart failure, or any other clinical manifestation of cardiovascular event after 5 years.
Secondary objectives:
- To compare the incidence of intermittent claudication.
- To compare the concentration of LDL cholesterol.
- To compare the atherogenic ratio Total cholesterol/HDL and LDL/HDL.
- To compare the metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose).
- To compare blood pressure.
- To compare the response to ergometry tests.
- To compare the incidence of Cancer.
- To compare the cognitive decline.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed Consent
Clinical: Unstable coronary disease
- Acute Myocardial Infarction
- Unstable Angina
- Chronic Coronary Disease at high risk for event
Exclusion Criteria:
- Age < 20 or > 75 years (or life expectancy lower than 5 years).
- Patients already planned for revascularization.
- Patients submitted to revascularization in the last 6 months
- Grade II-IV Heart failure.
- Left ventricle dysfunction with ejection fraction lower than 35%.
- Patients unable to follow a protocol.
- Patients with severe uncontrol of Diabetes Mellitus, or those with Renal Insufficiency with plasma creatinine higher than 2mg/dl, or cerebral complications of Diabetes mellitus.
Other chronic diseases:
- Psychiatric diseases
- Renal Insufficiency
- Chronic Hepatopathy
- Active Malignancy
- COPD
- Diseases of the digestive tract Endocrine disorders
- Patients participating in other Clinical trials (in the enrollment moment or 30 days prior).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924937
Locations
| Spain | |
| Reina Sofia University Hospital | |
| Cordoba, Spain, 14001 | |
Sponsors and Collaborators
Hospital Universitario Reina Sofia
Investigators
| Principal Investigator: | Francisco Perez-Jimenez, MD,PhD | Reina Sofia University Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Francisco Perez Jimenez, Chief of Internal Medicine Unit, Hospital Universitario Reina Sofia |
| ClinicalTrials.gov Identifier: | NCT00924937 History of Changes |
| Other Study ID Numbers: | CORDIOPREV |
| Study First Received: | June 18, 2009 |
| Last Updated: | April 6, 2013 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Hospital Universitario Reina Sofia:
|
Cardiovascular events Blood pressure Incidence of Cancer Cognitive decline |
Mediterranean Diet Secondary Prevention Low fat diet |
Additional relevant MeSH terms:
|
Angina, Unstable Neoplasms Infarction Myocardial Infarction Cognition Disorders Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Chest Pain Pain Signs and Symptoms Ischemia Pathologic Processes Necrosis Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013