The aim of study is to compare the effect of streptokinase on ST segment resolution among diabetic patients with acute myocardial infarction with non diabetics. We prepare a trial and patients with myocardial infarction who admitted during first 6 hours of onset will be included. Definite diagnosis of acute myocardial infarction performed by ST elevation in ECG and cardiac enzymes assessment during admission period. Informed consent was done. demographics and medical history were registered. All of our patients were gone under 12 leads ECG and routine labs. streptokinase injected to them with 1.5 million units, diluted in 100 ml of saline during 1 hour. ECG repeated 3 hours after injection and FBS was evaluated the next morning. the rate of ST resolution was measured. NAS was used to assess pain reduction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052722445N1
Registration date:2015-07-18, 1394/04/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-18, 1394/04/27
Registrant information
Name
Seyyedh Mahboobeh Rezanezhad
Name of organization / entity
Shahid Beheshti Medical University
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 6612
Email address
m.rezanezhad@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Streptokinase on ST segment Resolution among diabetic patients with acute myocardial infarction
Public title
Acute myocardial infarction management
Purpose
Treatment
Inclusion/Exclusion criteria
Patients with acute chest pain or other symptoms of AMI who referred to Firoozabadi Hospital during the first 6 hours of onset included in this study. Patients who have MI in their past medical history or those with LBBB in addition to patients who received SK for any reason excluded from this study.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
342
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
Shahid Beheshti Medical University
Street address
Daneshjoo Blvd
City
Tehran
Postal code
Approval date
2013-05-13, 1392/02/23
Ethics committee reference number
69
Health conditions studied
1
Description of health condition studied
Acute Myocardial Infarction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
ST resolution
Timepoint
Three hours after SK injection
Method of measurement
ECG
Secondary outcomes
1
Description
Pain reduction
Timepoint
Three hours after SK injection
Method of measurement
Numerical Rating Scale (NRS)
Intervention groups
1
Description
1.5 million units of IV Streptokinase diluted in 100 ml of Saline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozabadi Hospital
Full name of responsible person
Seyyedeh Mahboobeh Rezanezhad
Street address
Fadaeian-e-eslam St, Shahreray
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Mrs. Nouroozi
Street address
Parvaneh st., Yaman st., Chamran highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti Medical University
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
Shahid Beheshti Medical University
Full name of responsible person
Seyyedeh Mahboobeh Rezanezhad
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
No.3, Havizi st., Fakoori st., North Amirabad
City
Tehran
Postal code
Phone
+98 21 8895 6612
Fax
Email
rezanezhad.mahboobeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Seyyedeh Mahboobeh Rezanezhad
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
No 3, Havizi st., Fakoori st.,North Amirabad
City
Tehran
Postal code
Phone
+98 21 8895 6612
Fax
Email
rezanezhad.mahboobeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Seyyedeh Mahboobeh Rezanezhad
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
No.3, Havizi st., Fakoori st., North Amirabad
City
Tehran
Postal code
Phone
+98 21 8895 6612
Fax
Email
rezanezhad.mahboobeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)