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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004478-25 | EudraCT Number |
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| Name | Class |
|---|---|
| University Hospital, Akershus | OTHER |
| Asker & Baerum Hospital | OTHER |
| Helse Stavanger HF | OTHER_GOV |
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The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.
The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke, revascularizations or hospitalization for new or worsened heart failure with at least 30%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pikasol | Active Comparator | Pikasol®, 3 capsules (1.8 g EPA+DHA)/day |
|
| Corn oil | Placebo Comparator | 3x capsules of corn oil pr day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pikasol | Drug | Pikasol®, 3 capsules (1.8 g EPA+DHA)/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. | 24months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of new onset atrial fibrillation | 24months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harald Arnesen, MD Phd | Center for Clinical Heart Research | Study Chair |
| Svein Solheim, MD phd | Center for Clinical Heart Research | Study Director |
| Ingebjørg Seljeflot, Phd | Center for Clinical Heart Research | Study Director |
| Kristian Laake, MD | Center for Clinical Heart Research | Principal Investigator |
| Peder Myhre, MD | Center for Clinical Heart Research | Principal Investigator |
| Are A Kalstad, MD | Center for Clinical Heart Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asker and Bærum Hospital | Rud | Bærum | 1309 | Norway | ||
| Akershus university hospital HF |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34742136 | Derived | Chiva-Blanch G, Bratseth V, Laake K, Arnesen H, Solheim S, Schmidt EB, Badimon L, Seljeflot I. One year of omega 3 polyunsaturated fatty acid supplementation does not reduce circulating prothrombotic microvesicles in elderly subjects after suffering a myocardial infarction. Clin Nutr. 2021 Dec;40(12):5674-5677. doi: 10.1016/j.clnu.2021.10.007. Epub 2021 Oct 20. | |
| 33650449 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C077446 | Pikasol |
| D004281 | Docosahexaenoic Acids |
| D005231 | Fatty Acids, Unsaturated |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Corn oil | Other | Corn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid), unchanged and according to the manufacturer |
|
| Lørenskog |
| 1478 |
| Norway |
| Oslo University Hospital(Ullevaal) | Oslo | 0424 | Norway |
| Stavanger University Hospital | Stavanger | Norway |
| Kalstad AA, Myhre PL, Laake K, Opstad TB, Tveit A, Solheim S, Arnesen H, Seljeflot I. Biomarkers of ageing and cardiac remodeling are associated with atrial fibrillation. Scand Cardiovasc J. 2021 Aug;55(4):213-219. doi: 10.1080/14017431.2021.1889653. Epub 2021 Mar 2. |
| 33191772 | Derived | Kalstad AA, Myhre PL, Laake K, Tveit SH, Schmidt EB, Smith P, Nilsen DWT, Tveit A, Fagerland MW, Solheim S, Seljeflot I, Arnesen H; OMEMI Investigators. Effects of n-3 Fatty Acid Supplements in Elderly Patients After Myocardial Infarction: A Randomized, Controlled Trial. Circulation. 2021 Feb 9;143(6):528-539. doi: 10.1161/CIRCULATIONAHA.120.052209. Epub 2020 Nov 15. |
| 31881852 | Derived | Kalstad AA, Tveit S, Myhre PL, Laake K, Opstad TB, Tveit A, Schmidt EB, Solheim S, Arnesen H, Seljeflot I. Leukocyte telomere length and serum polyunsaturated fatty acids, dietary habits, cardiovascular risk factors and features of myocardial infarction in elderly patients. BMC Geriatr. 2019 Dec 27;19(1):376. doi: 10.1186/s12877-019-1383-9. |
| 24928284 | Derived | Laake K, Myhre P, Nordby LM, Seljeflot I, Abdelnoor M, Smith P, Tveit A, Arnesen H, Solheim S. Effects of omega3 supplementation in elderly patients with acute myocardial infarction: design of a prospective randomized placebo controlled study. BMC Geriatr. 2014 Jun 13;14:74. doi: 10.1186/1471-2318-14-74. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001145 | Arrhythmias, Cardiac |
| D008055 |
| Lipids |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |