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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| omega 3 | Active Comparator | receive omega 3 in addition to standard treatment |
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| control | No Intervention | This group is without omega 3 : just receives standard treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega 3 | Drug | 3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamshid Salamzadeh, PhD | SBMU School of Pharmacy | Principal Investigator |
| farzaneh foroughinia, phD | Shiraz University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moddaress Hospital | Tehran | Tehran Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23134549 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omega 3 | receive omega 3 in addition to standard treatment |
| FG001 | Control | This group is without omega 3 : just receives standard treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Omega 3 | receive omega 3 in addition to standard treatment |
| BG001 | Control | This group is without omega 3 : just receives standard treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Cardiac Necrosis Biomarkers (CKMB, Troponin I) | difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention | Posted | Median | Inter-Quartile Range | ng/ml | 8 and 24 hrs after percutaneous coronary intervention |
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| Primary | Inflammation Marker (CRP) | difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention | Posted | Median | Inter-Quartile Range | mg/l | 8 and 24 hrs after percutaneous coronary intervention |
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| Secondary | MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death | Posted | Number | participants | 30 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omega 3 | receive omega 3 in addition to standard treatment | 0 | 43 | 0 | 43 | ||
| EG001 | Control | This group is without omega 3 : just receives standard treatment | 0 | 47 | 0 | 47 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Jamshid Salamzadeh | Shaheed Beheshti Medical University | 00982188662334 | j.salamzadeh@yahoo.com |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |
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| Male |
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