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In the everyday practice cardiovascular prevention in people at high risk is still unsatisfactory and treatments with documented efficacy are generally under-used.
Polyunsaturated fatty acids of marine origin (n-3 PUFA) are the latest more promising strategy to improve prognosis in these patients.
The Risk and Prevention study combines an epidemiological and an experimental approach in order to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-3 PUFA | Experimental |
| |
| Olive oil | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-3 Polyunsaturated Fatty Acids | Drug | Each subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA |
|
| Measure | Description | Time Frame |
|---|---|---|
| cardiovascular deaths and hospitalization for cardiovascular causes | 5 years |
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Inclusion Criteria:
Multiple risk factors:
Previous manifestations of atherosclerotic disease (ischemic stoke, transient ischemic attack [TIA], peripheral artery disease, previous arterial revascularisation procedures, angina pectoris)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tombesi Massimo, MD | Centro Studi e Ricerca in Medicina Generale, Monza, Italy | Study Chair |
| Tognoni Gianni, MD | Mario Negri Institute for Pharmacological Research, Milan, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mario Negri Institute for Pharmacological Research | Milan | 20156 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23656645 | Derived | Risk and Prevention Study Collaborative Group; Roncaglioni MC, Tombesi M, Avanzini F, Barlera S, Caimi V, Longoni P, Marzona I, Milani V, Silletta MG, Tognoni G, Marchioli R. n-3 fatty acids in patients with multiple cardiovascular risk factors. N Engl J Med. 2013 May 9;368(19):1800-8. doi: 10.1056/NEJMoa1205409. | |
| 20509875 | Derived |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D006937 | Hypercholesterolemia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo: Olive oil | Drug | Each subject assigned to the control group will receive 1 g/day capsule of olive oil. |
|
| Rischio and Prevenzione Investigators. Efficacy of n-3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice. Trials. 2010 May 28;11:68. doi: 10.1186/1745-6215-11-68. |
| D014652 | Vascular Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |