Coronary Artery Disease Clinical Trial
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:
1. The newly Israeli Food Frequency Questionnaire (FFQ) will be used to examine dietary
intake of other nutritional habits/patterns and its relationship to the study outcomes.
2. The Hebrew language SF-36 health survey will be used to examine general health status.
3. The Back questionnaires will be use to examine possible beneficial effects of fish oil
supplementation on depressive symptomatology.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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