Protocol summary

Summary
PCI is the only way which can reduce infarct size in heart muscle. The purpose of this study is to compare adhesion molecules before and after of streptokinase infusion in patients with acute MI. 40 patients with chest pain with diagnosis of acute MI who are candidates for receiving Streptokinase without history of hemorrhagic stroke, bland CVA in past year, brain neoplasm, active bleeding, aortic dissection, and pericarditis are included in the study. Intervention is Streptokinase infusion which infuses during 12 hours of chest pain and its side effects are bleeding and hypotension.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812122337N1
Registration date: 2010-05-04, 1389/02/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-05-04, 1389/02/14
Registrant information
Name
Mani Mofidi
Name of organization / entity
Iran Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 8098
Email address
mofidim@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Iran University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Adhesion molecules before and after of streptokinase infusion in patients with acute MI
Public title
Comparison of Adhesion molecules before and after of streptokinase infusion in patients with acute MI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of acute MI referred to the emergency room and candidates of streptokinase infusion Exclusion criteria: Contraindication of streptokinase, previous hemorrhagic stroke, bland CVA in the past year, brain neoplasm, active bleeding, aortic dissection or pericarditis
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Blvd, before Chamran Blvd.
City
Tehran
Postal code
Approval date
2031-09-12, 1410/06/21
Ethics committee reference number
897

Health conditions studied

1

Description of health condition studied
Acute MI
ICD-10 code
I21.0
ICD-10 code description
Acute transmural myocardial infarction of anterior wall

Primary outcomes

1

Description
Bleeding
Timepoint
Every 6 hours
Method of measurement
check of PT,PTT,INR

Secondary outcomes

1

Description
Hypotension
Timepoint
Every 2o min
Method of measurement
cuff pressure

Intervention groups

1

Description
streptokinase, 1.5 million IU, single dose IV infusion
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research center of Iran University of Medical Sciences
Full name of responsible person
Mrs Malmir
Street address
Hemmat bolivar, before Chamran bolivar
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center of Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mani Mofidi
Position
Emergency Medicine physician
Other areas of specialty/work
Street address
Sattar Khan Ave, Niayesh St, Rasool Akram hospital, Emergency department
City
Tehran
Postal code
1997959363
Phone
+98 21 6651 8098
Fax
+98 21 6652 5327
Email
mofidim@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Saidi
Position
Pediatric Physician, Emergency Medicine Felowship
Other areas of specialty/work
Street address
Emergency department, Rasool Akram hospital, Niayesh St, Sattar Khan Ave
City
Tehran
Postal code
1997959363
Phone
+98 21 6651 8098
Fax
+98 21 6652 5327
Email
drhsaidi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mani Mofidi
Position
Emergency Medicine
Other areas of specialty/work
Street address
Sattar khan Ave, Niayesh St, Rasool Akram Hospital, Emergency department
City
Tehran
Postal code
1997959363
Phone
+98 21 6651 8098
Fax
+98 21 6652 5327
Email
mofidim@iums.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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