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Researchers

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

AGENDA

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
    Discussant
    Dr. Kris-Etherton
  • 10:00 a.m. - 10:15 a.m.
    Break
  • 10:15 a.m. - 11:00 a.m.
    CVD Report: Summary of Conclusions
    Dr. Jacobson
    Discussant
    Dr. Guallar
  • 11:00 a.m. - 11:30 a.m.
    Discussion: Evidence and Need for Trial
    All
  • 11:30 a.m. - 12:00 noon
    Recommendations for Research to Help
    Prepare or complement a Trial
    All
  • 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)
  • 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
    All
  • 2:30 p.m. - 3:30 p.m.
    Secondary Prevention Patients
    Moderator: Dr. Sacks
    All
  • 3:30 p.m. - 4:00 p.m.
    Break
  • 4:00 p.m. - 5:00 p.m.
    Primary Prevention for High-Risk Populations
    Moderator: Dr. Appel
    All
  • 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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