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)

NCT01521845 | Completed Phase 3 Results

• 1 other identifier: 90-1-94-8048
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Arteriosclerosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death

  30 days

Study Arms (2)

omega 3

ACTIVE COMPARATOR

receive omega 3 in addition to standard treatment

Drug: omega 3

control

NO INTERVENTION

This group is without omega 3 : just receives standard treatment

Interventions

omega 3 DRUG

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

Also known as: fish oil

omega 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• candidate of elective PCI
• treatment with aspirin at least 5 days before PCI

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Moddaress Hospital

Tehran, Tehran Province, Iran

Location

Related Publications (1)

• 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.

  PMID: 23134549 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Docosahexaenoic Acids; Fish Oils

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Results Point of Contact

• Title: Dr.Jamshid Salamzadeh
• Organization: Shaheed Beheshti Medical University

j.salamzadeh@yahoo.com

00982188662334

Study Officials

• Jamshid Salamzadeh, PhD

  SBMU School of Pharmacy

  PRINCIPAL INVESTIGATOR

• farzaneh foroughinia, phD

  Shiraz University of Medical Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 31, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 10, 2012
• Results First Posted: July 9, 2012

Record last verified: 2012-12

Locations

IR (1)