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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jamshid Salamzadeh, PhD, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01521845
First received: January 19, 2012
Last updated: December 6, 2012
Last verified: December 2012

January 19, 2012
December 6, 2012
January 2012
May 2012   (final data collection date for primary outcome measure)
  • Cardiac Necrosis Biomarkers (CKMB, Troponin I) [ Time Frame: 8 and 24 hrs after percutaneous coronary intervention ] [ Designated as safety issue: No ]
    difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention
  • Inflammation Marker (CRP) [ Time Frame: 8 and 24 hrs after percutaneous coronary intervention ] [ Designated as safety issue: No ]
    difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention
  • Cardiac necrosis biomarkers (CKMB, Troponin I) [ Time Frame: 4 and 24 hrs after percutaneous coronary intervention ] [ Designated as safety issue: No ]
    difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention
  • Inflammation Marker (CRP) [ Time Frame: 8 and 24 hrs after percutaneous coronary intervention ] [ Designated as safety issue: No ]
    difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention
Complete list of historical versions of study NCT01521845 on ClinicalTrials.gov Archive Site
MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Coronary Arteriosclerosis
Drug: omega 3
3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
Other Name: fish oil
  • Active Comparator: omega 3
    receive omega 3 in addition to standard treatment
    Intervention: Drug: omega 3
  • No Intervention: control
    This group is without omega 3 : just receives standard treatment
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01521845
90-1-94-8048
No
Jamshid Salamzadeh, PhD, Shaheed Beheshti Medical University
Shahid Beheshti Medical University
Not Provided
Principal Investigator: Jamshid Salamzadeh, PhD SBMU School of Pharmacy
Study Director: farzaneh foroughinia, phD Shiraz University of Medical Sciences
Shahid Beheshti Medical University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP