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
  Purpose

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 Intervention Phase
Coronary Arteriosclerosis
Drug: omega 3
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521845

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

No publications provided by Shahid Beheshti Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jamshid Salamzadeh, PhD, PhD, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT01521845     History of Changes
Other Study ID Numbers: 90-1-94-8048
Study First Received: January 19, 2012
Results First Received: May 31, 2012
Last Updated: December 6, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti Medical University:
elective percutaneous coronary intervention
hs-CRP
CKMB and troponin I

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Inflammation
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Pathologic Processes
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014