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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201402078307N5 |
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Date of registration:
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2014-10-10 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of omega-3 in reduction of myocardal damage in patients with myocardial infarctions who undergoing streptokinase therapy
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Scientific title:
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A Randomized placebo controlled trial of Omega-3 on Plasma Level of Cardiac Troponin-I and Creatinine Kinase- MB in patients with myocardial infarctions who undergoing streptokinase therapy |
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Date of first enrolment:
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2013-12-21 |
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Target sample size:
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100 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/8731 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: -.
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Phase:
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2-3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Dr. Taher Entezari-maleki
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Address:
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Faculty of pharmacy, Daneshgah Street
0000984113392593
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 1334 4798 |
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Email:
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tentezari@gmail.com |
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Affiliation:
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Tabriz University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: myocardial infarction patients; age 18-80; undergoing of thrombolytic therapy with streptokinase; filling of consent form. Exclusion Criteria: Elevation of CK-MB and cTnI before injection of streptokinase; history of CABG during last three months; history of previous MI; renal dysfunction (creatinine above 2.5 mg/dl); contraindication of streptokinase therapy; acute MI; cardiogenic shock; Hypersensitivity to aspirin or clopidogrel or omega-3 and streptokinase injection.
Exclusion criteria:
Age minimum:
18 years
Age maximum:
80 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myocardial Infarction
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Myocardial Infarction.
Myocardial Infarction
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I23-I25.8
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Intervention(s)
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Intervention 1: Intervention: in omega-3 group All patients will be received 3 grams of omega-3 before streptokinase injection. Intervention 2: Control: In the control group, patients only will be given the standard treatment.
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Control: In the control group, patients only will be given the standard treatment.
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Intervention: in omega-3 group All patients will be received 3 grams of omega-3 before streptokinase injection.
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Treatment - Drugs
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Primary Outcome(s)
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CK-MB level. Timepoint: Before, 8 and 24 hours after streptokinase injection. Method of measurement: ELISA kits.
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Secondary Outcome(s)
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CTnI level. Timepoint: Before, 8 and 24 hours after streptokinase injection. Method of measurement: ELISA kits.
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Source(s) of Monetary Support
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Vice chancellor for research of Tabriz University of Medical Sciences.
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Ethics review
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Status: Approved
Approval date:
Contact:
Committee on Medical Ethics of Tabriz University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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