Working Group on Future Clinical Research Directions on
Omega-3 Fatty Acids and Cardiovascular Disease
Bethesda Marriott Hotel
5151 Pooks Hill Road
Bethesda, MD 20817
June 2, 2004
Full Report of the Working Group
- 8:00 a.m. - 8:30 a.m.
- Registration and Continental Breakfast
- 8:30 a.m. - 8:45 a.m.
- Welcome and Charge to the Working Group
- Dr. Obarzanek, Dr. Coates, Dr. Grundy
Part I: Review of Evidence-Based Reports
Moderator: Dr. Appel
- 8:45 a.m. - 9:15 a.m.
- Summary of Methods and Approach of Evidence-Based Reports
- Dr. Balk
- 9:15 a.m. - 10:00 a.m.
- CVD Risk Factor Report: Summary of Conclusions
- Dr. Siscovick
- Dr. Kris-Etherton
- 10:00 a.m. - 10:15 a.m.
- 10:15 a.m. - 11:00 a.m.
- CVD Report: Summary of Conclusions
- Dr. Jacobson
- Dr. Guallar
- 11:00 a.m. - 11:30 a.m.
- Discussion: Evidence and Need for Trial
- 11:30 a.m. - 12:00 noon
- Recommendations for Research to Help
- Prepare or complement a Trial
- 12:00 noon
- Working Lunch
Part II: Considerations of Intervention
Moderator: Dr. Albert
- 12:30 p.m. - 1:00 p.m.
- Possible Omega-3 Fatty Acid Interventions
- Dr. Harris
- 1:00 p.m. - 1:30 p.m.
- Alpha Omega Trial: Example of Two Interventions
- Dr. Geleijnse
Part III: Considerations of Types of Trials
Moderator: Dr. Grundy
For the following three types of trial populations (acute coronary syndrome patients, secondary prevention patients, and primary prevention for high-risk populations), discuss design and implementation considerations regarding:
- Eligibility criteria to define the population
- Trial setting (e.g., multiple clinical centers, mail)
- Number of arms
- Type of Omega-3 (e.g., fish-based, plant-based)
- Delivery (e.g., supplement, food)
- Adherence issues
- Outcomes (primary, secondary, safety, others)
- Critical design assumptions
- Effect size
- Possible event rates
- Possible sample size (rough estimate)
- 1:30 p.m. - 2:30 p.m.
- Acute Coronary Syndrome Patients
- Moderator: Dr. Blazing
- 2:30 p.m. - 3:30 p.m.
- Secondary Prevention Patients
- Moderator: Dr. Sacks
- 3:30 p.m. - 4:00 p.m.
- 4:00 p.m. - 5:00 p.m.
- Primary Prevention for High-Risk Populations
- Moderator: Dr. Appel
- 5:00 p.m. - 5:30 p.m.
- Wrap-Up and Next Steps
- Dr. Grundy, Dr. Obarzanek
- 5:30 p.m. Adjourn