Protocol summary

Summary
A total of 90 patients, without age limit with acute myocardial infarction in coronary care unit admission Gonabad city 22 Bahman hospital will be enrolled in this study. Patients will be randomized into two groups 1- Intervention: receiving 1 gram per day of omega-3 and 2- Control: receiving placebo for the same amount. The intervention will be start following the diagnose of MI. In addition to routine medical procedures involving the measurement of plasma troponin I and CK-MB as a myocardial injury, In all patients on admission, 24 and 48 hours later, at discharge (5 days after admission) and 30, 60 and 90 days later, ALT liver enzymes will be measured. Demographic data from the questionnaires will be recorded and information of cardiac function including the infarct site, its size, date of acceptance after the first symptoms, systolic pressure, diastolic pressure, echocardiographic data will be recorded for each sample. Patients with a history of liver disease, cardiogenic shock, heart failure, history of stroke in the last 6 months will be excluded. Omega-3 oils can be used in the prevention of liver disease caused by the myocardial infarction If the protective effect of omega 3 on liver injury induced by myocardial infarction is confirmed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013060213550N1
Registration date: 2014-07-05, 1393/04/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-07-05, 1393/04/14
Registrant information
Name
Maryam Moghimian
Name of organization / entity
Gonabad University of Medical Scences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 5027
Email address
moghimian.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Gonabad University of Medical Sciences
Expected recruitment start date
2013-07-11, 1392/04/20
Expected recruitment end date
2014-07-11, 1393/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The protective effects of omega-3 intake on liver injury in patients with acute myocardial infarction after reperfusion
Public title
Effect of omega3 oil on myocardial infarction induced liver injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: patients with myocardial infarction accepted in ccu Exclusion Criteria: Patients with a history of liver disease, cardiogenic shock, heart failure and History of stroke within the last 6 months Will be excluded.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Postal code
Approval date
2013-05-28, 1392/03/07
Ethics committee reference number
1025/ص/92

Health conditions studied

1

Description of health condition studied
myocardial infarction
ICD-10 code
IX
ICD-10 code description
Diseases of the circulatory system

Primary outcomes

1

Description
liver injury
Timepoint
Admission every day and then a week, then a month or two later
Method of measurement
Measurement of ALT

Secondary outcomes

empty

Intervention groups

1

Description
The Intervention group will receive 1 gram of Omega-3 capsules per day orally for 3 months
Category
Treatment - Drugs

2

Description
The Control group will receive 1 gram of Placebo capsules per day orally for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Street address
City
Gonabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Gonabad University of Medical Sciences
Full name of responsible person
Maryam Moghimian
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran
City
Gonabad
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 Gonabad 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
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Moghimian
Position
Assistant Professor
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Postal code
Phone
+98 53 3722 5027
Fax
Email
moghimian.m@gmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Moghimian
Position
Assistant Professor
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Postal code
Phone
+98 53 3722 5027
Fax
Email
moghimian.m@gmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Moghimian
Position
PhD/Assistant Professor
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Asian Road, Khorasan Razavi, Iran
City
Gonabad
Postal code
Phone
+98 53 3722 5027
Fax
Email
moghimian.m@gmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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