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)

Coronary Arteriosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521845
• Other study ID #: 90-1-94-8048
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2012
• Last updated: December 6, 2012
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: December 2012
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Drug:
• omega 3
3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI

Locations

Country	Name	City	State
Iran, Islamic Republic of	Moddaress Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death		30 days	No