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
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
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
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)
  • Intervention(s)
    • Number of arms
    • Type of Omega-3 (e.g., fish-based, plant-based)
    • Delivery (e.g., supplement, food)
    • Dose
    • Blinding
    • Adherence issues
  • Outcomes (primary, secondary, safety, others)
  • Critical design assumptions
    • Effect size
    • Possible event rates
    • Duration
    • 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


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