Study of the Effect of omega3 on Biomarkers of Cardiac Necrosis (CKMB and Troponin I) and Inflammation Marker (CRP) After Elective Percutaneous Coronary Intervention (PCI)

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of omega 3 on biomarkers of cardiac necrosis(CKMB and troponin I) and inflammation marker CRP.

Detailed Description
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Percutaneous coronary intervention (PCI) has become the most common form of coronary revascularization worldwide. Although PCI is a safe procedure, it may have multiple risks including bleeding, coronary dissection, abrupt vessel closure, and myocardial necrosis. It is estimated that approximately 25% of patients undergoing PCI have significant postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations and approximately 50% of patients have significant post-procedural troponin elevations. Initially, it was felt these elevations were simple enzyme leaks with no long-term implications. Now, several studies have demonstrated that periprocedural infarction is associated with short-, intermediate-, and long-term adverse outcomes, most notably mortality. Pretreatment with antiplatelets such as aspirin and clopidogrel play an important role in reducing cardiovascular events (CV events) following PCI. Omega -3 polyunsaturated fatty acids (PUFAs) have antiplatelet effect. It may also improve response to aspirin and clopidogrel in low-response patients. This study is a randomized clinical trial (RCT) evaluating the effect of omega 3 supplement [with 400mg Eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA)] on biomarkers of cardiac necrosis (CKMB and troponin I) in patients undergoing elective PCI. Eighty patients planed to do elective PCI will be categorized into two groups. The first group will be received standard regimen for PCI (aspirin, clopidogrel, and heparin) and the second group will be treated with standard regimen in addition to 3 gram omega 3 (12 hours before PCI). Blood samples will be drawn in all patients before and 8 and 24 h after intervention for cardiac biomarkers assessment (CK-MB, troponin I)and inflammation marker C-reactive protein (CRP). Major adverse cardiac events (MACE) will be evaluated as a second endpoint.

Official Title
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Phase 3 Study of Poly Unsaturated Fatty Acids of Omega 3 as an Anti Platelet Agent on Biomarkers of Cardiac Necrosis Including CKMB and Troponin I and Inflammation Marker CRP

Conditions
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Coronary Arteriosclerosis

Intervention / Treatment
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* Drug: omega 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: candidate of elective PCI treatment with aspirin at least 5 days before PCI Exclusion Criteria: high CKMB and troponin I level cardiac bypass in recent 3 months platelet count < 70×10 9/L sever chronic renal failure active bleeding treatment with glycoprotein IIb/IIIa inhibitors during PCI treatment with bivalirudin during PCI sensitivity to aspirin and clopidogrel

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: omega 3<br>receive omega 3 in addition to standard treatment | Drug: omega 3<br>* 3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI<br>* Other names: fish oil;|
| No Intervention: control<br>This group is without omega 3 : just receives standard treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Necrosis Biomarkers (CKMB, Troponin I) | difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention | 8 and 24 hrs after percutaneous coronary intervention | 
| Inflammation Marker (CRP) | difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention | 8 and 24 hrs after percutaneous coronary intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elective percutaneous coronary intervention, hs-CRP, CKMB and troponin I