The aim of this study was to determine of fast and slow intravenous streptokinase infusion effect on coronary re-perfusion in patients with acute myocardial infarction.
This was a randomized clinical trial, So that 100 patients with acute myocardial infarction were randomly selected for the intervention and comparison in two groups, intervention group (fast or half-hour intravenous infusion) and control group (one-hour infusion or slow )(50 patients in each group). Inclusion criteria were: 1- acute myocardial infarction with any contraindication for stereptokinase injection 2- Equal to or greater than one mm ST elevation in two contiguous leads and exclusion criteria were: 1- No ECG or echo to file.2- Not consent to participate in the study. Among 1.5 million units of streptokinase was administered to each patient in the two groups and ECG and Echo results before infusion and 6 hours after infusion and laboratory findings were recorded. Also Complications during and after injection were observed and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211205989N2
Registration date:2015-05-09, 1394/02/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-09, 1394/02/19
Registrant information
Name
Afrouz Mardi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3327 1159
Email address
a.mardi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fast and slow intravenous streptokinase infusion on coronary re-perfusion in patients with acute myocardial infarction.
Public title
Effect of fast and slow intravenous streptokinase infusion on coronary re-perfusion.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- acute myocardial infarction with any contraindication for stereptokinase injection
2-Equal to or greater than one mm ST elevation in two contiguous leads
Exclusion criteria: 1-No ECG or echo to file
2-Not consent to participate in the study
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
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
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences-Daneshgah St- Ardabil-Iran
City
Ardabil
Postal code
5618953121
Approval date
2010-04-26, 1389/02/06
Ethics committee reference number
8926/الف/11
Health conditions studied
1
Description of health condition studied
myocardial infarction
ICD-10 code
I21
ICD-10 code description
myocardial infarction specified as acute or with a stated duration of 4 weeks (28 days) or less from onset
Primary outcomes
1
Description
Coronary reperfusion
Timepoint
Before and 6 hours after infusion
Method of measurement
by decending of ST piece in ECG
Secondary outcomes
1
Description
Cardiac complications
Timepoint
before injection and 6 hours after injection
Method of measurement
ECG
2
Description
Hematologic effects
Timepoint
before injection and 6 hours after injection
Method of measurement
measurement of INR and PT
Intervention groups
1
Description
Intervention was in how to infusion of 1/5 million unit of streptokinase with zikinase Brand owned company of Zist Daru Danesh,Intervention 1: Rapid infusion in 5% Dextrose at 30 minutes and
Category
Treatment - Drugs
2
Description
Intervention 2: slowly infusion in 5% Dextrose at one hour.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Shokrdargahi Ahmad
Street address
Imam Khomeini Hospital- Ardabil-Iran
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Piri Hadi
Street address
Vice chancellor for research,Ardabil University of Medical Sciences
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Azari Mahnaz
Position
master science
Other areas of specialty/work
Street address
Educational management- Ardabil University of Medical Sciences
City
Ardabil
Postal code
5618985991
Phone
+98 45 1552 2088
Fax
Email
m.azari2010@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Shokrdargahi Ahmad
Position
internal specialist
Other areas of specialty/work
Street address
Imam Khomeini Hospital -Ardabil University of Medical Sciences
City
Ardabil
Postal code
5618985991
Phone
+98 45 1552 2088
Fax
Email
mahnaz380@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mardi Afrouz
Position
Master Sciences- Lecturer
Other areas of specialty/work
Street address
Health Faculty-Ardabil University of Medical Sciences
City
Ardabil
Postal code
5618953141
Phone
+98 45 1551 2810
Fax
+98 45 1551 2004
Email
a.mardi@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)