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)

NCT ID: NCT01521845

Last Updated: 2012-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-05-31

Brief 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.

Detailed 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.

Conditions

Coronary Arteriosclerosis

Keywords

elective percutaneous coronary intervention; hs-CRP; CKMB and troponin I

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

omega 3

receive omega 3 in addition to standard treatment

Group Type: ACTIVE_COMPARATOR

omega 3

Intervention Type: DRUG

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

control

This group is without omega 3 : just receives standard treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

omega 3

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

Intervention Type: DRUG

Other Intervention Names

fish oil

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jamshid Salamzadeh, PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jamshid Salamzadeh, PhD

Role: PRINCIPAL_INVESTIGATOR

SBMU School of Pharmacy

farzaneh foroughinia, phD

Role: STUDY_DIRECTOR

Shiraz University of Medical Sciences

Locations

Moddaress Hospital

Tehran, Tehran Province, Iran

Countries

Iran

References

Foroughinia F, Salamzadeh J, Namazi MH. Protection from procedural myocardial injury by omega-3 polyunsaturated fatty acids (PUFAs): is related with lower levels of creatine kinase-MB (CK-MB) and troponin I? Cardiovasc Ther. 2013 Oct;31(5):268-73. doi: 10.1111/1755-5922.12016.

Reference Type: DERIVED

PMID: 23134549 (View on PubMed)

Other Identifiers

90-1-94-8048

Identifier Type: -

Identifier Source: org_study_id