Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT00290056
Brief Summary:
We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients.
Detailed Description:
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.
Study:
NCT00290056
Study Brief:
Protocol Section:
NCT00290056