Protocol summary

Summary
The goal of study is evaluation the effect of magnesium on the inflamatory reactant in acute myocardial infarction,44 patients with acute ST elevation myocardial infarction who treated with streptokinase divided in 2 groups randomly, the serum sampel obtained of both groups initialy and 1gr magnesium injected in one group before streptokinase and then 8gr magnesium infused at 24 houres in this group(in compared to control group who didn"t take magnesium)and at 6,24,48 hours after injection of streptokinase serum sampels took from both groups and the level of blood complement,CRP levele and WBC count were compared between 2 groups.Diseased and conditions that affect complement,CRP level,WBC count and serum magnesium are the exclusion criteria.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105096309N1
Registration date: 2011-05-23, 1390/03/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-05-23, 1390/03/02
Registrant information
Name
Sanam Golshani
Name of organization / entity
kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 1424 2133
Email address
dr-hashemkazerani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Science
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2010-11-21, 1389/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous magnesium sulfate on blood complement,quantitative CRP level and leukocytes count in patient with acute myocardial infarction who treated with streptokinase
Public title
Effect of magnesium on acute myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with acute myocardial infarction who treated with streptokinase be enrolled in the study Exclusion criteria are:cardiogenic shock,systolic blood pressure<90,AV block grade2&3,illiac resection,renal failure,collagen vascular diseases,alcohol&drug abuse,chemotherapy and consumption of immunosuppresive drugs during a past year
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of Medical Science
Street address
Shahid Beheshti Bulvard,Kermanshah
City
kermanshah
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
7/420/6328

Health conditions studied

1

Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
Myocardial infarction specified as acute or with a stated duration of 4 weeks (28 dayes)or less from onset

Primary outcomes

1

Description
CH50
Timepoint
6,24&48 after injection of streptokinase
Method of measurement
Neflometry

2

Description
C3
Timepoint
6,24&48 hours ater injection of streptokinase
Method of measurement
Radial Immunodiffusion

3

Description
C4
Timepoint
6,24&48hours ater injection of streptokinase
Method of measurement
Radial Immunodiffusion

4

Description
CRP
Timepoint
6,24,48 houres after injection of streptokinase
Method of measurement
Elisa

5

Description
Leukocytes count
Timepoint
6,24,48 houres after injection of streptokinase
Method of measurement
CBC H1 method

Secondary outcomes

empty

Intervention groups

1

Description
1gr intravenus magnesium sulfate during 1 minute as a loading dose before streptokinase injection and 8gr magnesium sulfate infusion during 24 hours,we don"t use of placebo
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah Emam Ali Hospital
Full name of responsible person
Drhashem kazerani
Street address
Emam Ali Hospital,Shahid Beheshti Bulvard,Ker,amshah
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Hashem Kazerani
Street address
Emam Ali Hospital,Shahid Beheshti Bulvard,Kermanshahl
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University Of Medical Science
Full name of responsible person
Dr Hashem Kazerani
Position
Master Of Cardiology
Other areas of specialty/work
Street address
Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1836 0041
Fax
+98 83 1836 0043
Email
Dr-hashemkazerani@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University Of Medical Science
Full name of responsible person
Dr Hashem Kazerani
Position
Master of Cardiology
Other areas of specialty/work
Street address
Ema Ali Hospital,Shahid Beheshti Bulvard,Kermanshah
City
Kermanshah
Postal code
Phone
+98 988318360041
Fax
+98 83 1836 0043
Email
Dr-hashemkazerani@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Dr Hashem Kazerani
Position
Master of Cardiology
Other areas of specialty/work
Street address
Emam Ali Hospital,Shahid Beheshti Bulvard,Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1836 0041
Fax
+98 83 1836 0043
Email
Dr-hashemkazerani@kums.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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