A Phase 4 interventional study of Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA). in Coronary Artery Disease and Arrhythmia, sponsored by Sheba Medical Center. Status unknown at 2 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-11-04.
Sponsored by Sheba Medical Center · Phase 4, Interventional, and Treatment
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:
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 105 is below the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Sheba Medical Center is the lead sponsor of 677 studies on the registry; 63 are open to participants now.
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Exclusion Criteria:
3.6 gram oral supplementation for 6 months.
number of VT/VF episodes
Time frame: continous
All-cause mortality, cardiac mortality, recurrent and myocardial infarction.
Time frame: 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.
Time frame: 24 hours
Whether omega-3 PUFA supplementation exerts different effects according to ischemia severity assessed by stress perfusion nuclear imaging.
Time frame: time of the test
The record gives a start of Nov 2005, a primary completion of Nov 2009 and a completion of Jun 2010. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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