Coronary Arteriosclerosis
Conditions
Keywords
elective percutaneous coronary intervention, hs-CRP, CKMB and troponin I
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.
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.
Interventions
DRUGomega 3
3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Necrosis Biomarkers (CKMB, Troponin I) | 8 and 24 hrs after percutaneous coronary intervention | difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention |
| Inflammation Marker (CRP) | 8 and 24 hrs after percutaneous coronary intervention | difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention |
Secondary
| Measure | Time frame |
|---|---|
| MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death | 30 days |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omega 3 receive omega 3 in addition to standard treatment | 43 |
| Control This group is without omega 3 : just receives standard treatment | 47 |
| Total | 90 |
Baseline characteristics
| Characteristic | Omega 3 | Control | Total |
|---|---|---|---|
| Age Continuous | 62 years STANDARD_DEVIATION 11 | 60 years STANDARD_DEVIATION 11 | 61 years STANDARD_DEVIATION 11 |
| Region of Enrollment Iran, Islamic Republic of | 43 participants | 47 participants | 90 participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 27 Participants | 33 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 47 |
| serious Total, serious adverse events | 0 / 43 | 0 / 47 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Omega 3 | Cardiac Necrosis Biomarkers (CKMB, Troponin I) | 13 ng/ml |
| Control | Cardiac Necrosis Biomarkers (CKMB, Troponin I) | 18 ng/ml |
p-value: 0.001Wilcoxon (Mann-Whitney)
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Omega 3 | Inflammation Marker (CRP) | 3 mg/l |
| Control | Inflammation Marker (CRP) | 6 mg/l |
p-value: 0.03Wilcoxon (Mann-Whitney)
Secondary
MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omega 3 | MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death | 0 participants |
| Control | MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death | 0 participants |
p-value: 1not comparable