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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01521845
Recruitment Status : Completed
First Posted : January 31, 2012
Results First Posted : July 9, 2012
Last Update Posted : December 10, 2012
Information provided by (Responsible Party):
Jamshid Salamzadeh, PhD, Shaheed Beheshti Medical University

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.

Condition or disease Intervention/treatment Phase
Coronary Arteriosclerosis Drug: omega 3 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: omega 3
receive omega 3 in addition to standard treatment
Drug: omega 3
3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
Other Name: fish oil
No Intervention: control
This group is without omega 3 : just receives standard treatment

Primary Outcome Measures :
  1. Cardiac Necrosis Biomarkers (CKMB, Troponin I) [ Time Frame: 8 and 24 hrs after percutaneous coronary intervention ]
    difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention

  2. Inflammation Marker (CRP) [ Time Frame: 8 and 24 hrs after percutaneous coronary intervention ]
    difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention

Secondary Outcome Measures :
  1. MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01521845

Iran, Islamic Republic of
Moddaress Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Principal Investigator: Jamshid Salamzadeh, PhD SBMU School of Pharmacy
Study Director: farzaneh foroughinia, phD Shiraz University of Medical Sciences

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jamshid Salamzadeh, PhD, PhD, Shaheed Beheshti Medical University Identifier: NCT01521845     History of Changes
Other Study ID Numbers: 90-1-94-8048
First Posted: January 31, 2012    Key Record Dates
Results First Posted: July 9, 2012
Last Update Posted: December 10, 2012
Last Verified: December 2012

Keywords provided by Jamshid Salamzadeh, PhD, Shaheed Beheshti Medical University:
elective percutaneous coronary intervention
CKMB and troponin I

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases