A Phase 3 interventional study of omega 3 in Coronary Arteriosclerosis, sponsored by Shahid Beheshti University of Medical Sciences. Completed at 1 site in Iran. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-12-10.
Sponsored by Shahid Beheshti University of Medical Sciences · Phase 3, Interventional, and Prevention
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.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 104 is below the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Shahid Beheshti University of Medical Sciences is the lead sponsor of 229 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
receive omega 3 in addition to standard treatment
Drug: omega 3
This group is without omega 3 : just receives standard treatment
3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
Also known as: fish oil
Cardiac Necrosis Biomarkers (CKMB, Troponin I)
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
Inflammation Marker (CRP)
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
MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death
Time frame: 30 days
| Milestone | Omega 3 | Control |
|---|---|---|
| Started | 52 | 52 |
| Completed | 43 | 47 |
| Not completed | 9 | 5 |
difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention
| ng/ml | Omega 3 | Control |
|---|---|---|
| Cardiac Necrosis Biomarkers (CKMB, Troponin I) | 13 (10 to 18) | 18 (13 to 23) |
difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention
| mg/l | Omega 3 | Control |
|---|---|---|
| Inflammation Marker (CRP) | 3 (1 to 10) | 6 (2 to 15) |
| participants | Omega 3 | Control |
|---|---|---|
| MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death | 0 | 0 |
Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omega 3 | — | 0/43 (0%) | 0/43 (0%) |
| Control | — | 0/47 (0%) | 0/47 (0%) |
| Age Continuous(years) | Omega 3 | Control | Total |
|---|---|---|---|
| Mean | 62 ± 11 | 60 ± 11 | 61 ± 11 |
| Sex: Female, Male(Participants) | Omega 3 | Control | Total |
|---|---|---|---|
| Female | 16 | 14 | 30 |
| Male | 27 | 33 | 60 |
| Region of Enrollment(participants) | Omega 3 | Control | Total |
|---|---|---|---|
| Iran, Islamic Republic of | 43 | 47 | 90 |
The record gives a start of Jan 2012, a primary completion of May 2012 and a completion of May 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2012, 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omega-3 fatty acid
Shahid Beheshti University of Medical Sciences →