Moddaress Hospital
Tehran, Tehran Province, Iran
NCT Number: NCT01521845
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 3
Tehran, Tehran Province, Iran
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
Other names: fish oil
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
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
Time frame: 30 days
Shahid Beheshti University of Medical Sciences
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06299735
Arterial Occlusive Diseases, Arteriosclerosis
Ankara, Çankaya, Turkey (Türkiye)
View Trial DetailsNCT01777503
Acute Coronary Syndrome, Arterial Occlusive Diseases
Reggio Emilia, Italy
View Trial DetailsNCT00129038
Arterial Occlusive Diseases, Arteriosclerosis
Dublin, Ireland
View Trial DetailsNCT00357955
Arterial Occlusive Diseases, Arteriosclerosis
Providence, Rhode Island, United States
View Trial Details