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We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients.
This is a randomized, placebo-controlled, crossover, double- blind interventional study. Patients will receive 3.6 g of EPA and DHA fish oil and placebo oil for 6 months, randomly, in a crossover design, with a four month washout period between treatments.
Randomization will be stratified by ejection fraction (≤ 35% or > 35%), and the type of the index arrhythmia (VT - spontaneous or inducible by electrophysiologic study (EPS), versus other - VF, SCD, Primary prevention - MADIT II).
Ischemia severity was chosen to be evaluated by Single Photon Emission Computed Tomography (SPECT) during stress (dipyridamol infusion).
Subcutaneous adipose-tissue biopsy, a biomarker considered the gold-standard for the objective assessment of long-term habitual dietary intake of fish and marine omega-3 PUFA (EPA and DHA) will be obtain.
Compliance will be monitored by counting returned capsules or bottles and by measuring the omega-3 PUFA composition in red blood cells (RBC).
Three different types of questionnaires will be used in this trial to obtain more information as to the additional potential benefit of omega-3 PUFA supplementation:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA). | Drug | 3.6 gram oral supplementation for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| number of VT/VF episodes | continous |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality, cardiac mortality, recurrent and myocardial infarction. | continous | |
| Atrial arrhythmia and non-sustained ventricular arrhythmia (non-sustained VT or ventricular premature complex (PVC)) as documented by ICD memory or 24 hour ECG (Holter) recording. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Luria, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Tel Aviv Sourasky Medical Center | Tel Aviv | 64239. | Israel | |||
| Sheba Medical Center, Heart Institute, Electrophysiology Unit |
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| 24 hours |
| Whether omega-3 PUFA supplementation exerts different effects according to ischemia severity assessed by stress perfusion nuclear imaging. | time of the test |
| Tel Litwinsky |
| Israel |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015118 | Eicosapentaenoic Acid |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
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