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
Objective: To evaluate the effect of omega-3 in myocardial infarction in patients undergoing streptokinase therapy. Design: A prospective, single blinded, randomized controlled trial on patients with myocardial infarction who undergoing streptokinase therapy. Setting and conduct: All patients with myocardial infarction who undergoing streptokinase therapy in Shahid Madani Hospital will be randomized (using permuted block randomization, block size 2, allocation ratio 1:1) in two groups of omega-3 treated (n=50) and control (n=50). Participants: All consented patients with myocardial infarction aged 18-80 who undergoing stereptokinase therapy. The exclusion criteria are elevation of CK-MB and cTnI at least 48 hours 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 injection; acute MI; cardiogenic shock; hypersensitivity to aspirin or clopidogrel or omega-3 and streptokinase injection. Intervention: In omega-3 group, all patients will be received totally 3 g oral omega-3 before streptokinase therapy. The control group will be received only standard treatment. Primary outcomes: Changes of CK-MB and cTnI level before, 8, and 24 hours after streptokinase injection in each groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402078307N5
Registration date:2014-10-10, 1393/07/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-10, 1393/07/18
Registrant information
Name
Taher Entezari-Maleki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
tentezarimaleki@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-12-21, 1392/09/30
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of omega-3 in reduction of myocardal damage in patients with myocardial infarctions who undergoing streptokinase therapy
Purpose
Prevention
Inclusion/Exclusion 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.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee on Medical Ethics of Tabriz University of Medical Sciences
Street address
Golgasht Street
City
Tabriz
Postal code
Approval date
2013-12-02, 1392/09/11
Ethics committee reference number
92143
Health conditions studied
1
Description of health condition studied
Myocardial Infarction
ICD-10 code
I23-I25.8
ICD-10 code description
Myocardial Infarction
Primary outcomes
1
Description
CK-MB level
Timepoint
Before, 8 and 24 hours after streptokinase injection
Method of measurement
ELISA kits
Secondary outcomes
1
Description
cTnI level
Timepoint
Before, 8 and 24 hours after streptokinase injection.
Method of measurement
ELISA kits
Intervention groups
1
Description
Intervention: in omega-3 group All patients will be received 3 grams of omega-3 before streptokinase injection.
Category
Treatment - Drugs
2
Description
Control: In the control group, patients only will be given the standard treatment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Heart Center of Tabriz
Full name of responsible person
Dr. Taher Entezari-Maleki
Street address
Shahid Madani Heart Center, Daneshghah Street
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tabriz University of Medical Sciences.
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Daneshghah street
City
tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tabriz University of Medical Sciences.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Taher Entezari-maleki
Position
Assistant professor/ Clinical pharmacist
Other areas of specialty/work
Street address
Faculty of pharmacy, Daneshgah Street
City
Tabriz
Postal code
0000984113392593
Phone
+98 41 1334 4798
Fax
-
Email
tentezari@gmail.com
Web page address
tentezari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Taher Entezari-maleki
Position
Assistant professor/ Clinical pharmacist
Other areas of specialty/work
Street address
Faculty of pharmacy, Daneshgah Street
City
Tabriz
Postal code
Phone
+98 41 3339 2593
Fax
+98 41 3334 4798
Email
tentezari@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)