Coronary Artery Disease
Conditions
Keywords
Fish oil supplement, n-3 PUFA, Cardiac function, Membrane incorporation, Inflammation, Clinical outcome
Brief summary
A large body of evidence has accumulated showing that n-3 PUFAs exert extensive cardiac effects. The development of commercial solutions of FO opens perspectives for therapeutic applications in patients with acute cardiac conditions.the 3 following hypotheses will be addressed in patients requiring cardiac surgery under cardiopulmonary bypass or after myocardial infarction:perioperative /post-PTCA intravenous fish oil modifies the composition of membrane phospholipids in platelets and cardiac cells, blunts the physiological response to cardiac surgery/myocardial infarction, and reduces the incidence of arrhythmias, and reduces the occurrence of systolic dysfunction.
Detailed description
A. Randomized trial in 40 cardiac surgery patients Early rapid infusion of fish oil (3 times in 24 hours) in cardiac surgery patients. B. Randomized trial 20 myocardial infarction patients (abandonned) Continuous infusion of the same dose over 24hrs in the myocardial infarction patients Additional trial in healthy volunteers (investigating physiological changes after cardiac study): -Open trial in 8 healthy lean volunteers to investigate the impact of the same 0.6 g/kg FO dose IV (Week 1: 3hrs), and then orally on week 2, on platelet n-3 PUFA incorporation, platelet function, heart rate and peak flow response to stress test.
Interventions
0.2 g/kg FO, 3 times in 24 hours, infused over 3 hours each in cardiac surgery, or continuous infusion of 0.6 g/kg post PTCA
DRUGSaline
3 infusions, perioperative or post-PTCA
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Coronary artery disease requiring elective surgical repair under cardiopulmonary bypass * Acute myocardial infarction requiring ICU management
Exclusion criteria
* Absence of consent * Ventricular ejection fraction \< 35% * Beating heart surgery or emergency surgery * Hypercholesterolemia \> 5 mmol/l * Thrombolysis * Chronic steroid therapy * Acute or chronic renal failure prior to surgery (plasma creatinine \> 150 umol/l) * Chronic coagulation disorder * Premenopausal female * Consumption of more than 3 times fish per week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incorporation of n-3 PUFA into platelet cell membrane and myocardial tissue | 48 hours | The primary outcome is the determination of magnitude of the incorporation and the time required for incorporation of omega-3 fatty acid cell membrane composition after short intravenous infusions was unknown until the present study (HPLC determination of fatty acid membrane composition in all patients) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory and metabolic response | From operation to ICU discharge (maximum 28 days) | cytokine determination, CRP, glucose control (blood levels and insulin requirements) in all patients |
| Global clinical outcome | From operation to hospital discharge (maximum 28 days) | length of mechanical ventilation, length of ICU and hospital stay in all patients |
| Myocardial recovery after surgery | From operation to hospital discharge (maximum 28 days) | Holter monitoring during cardiac surgery or for 72 hours |
Countries
Switzerland
Outcome results
None listed