Experimental evidence suggests that cyclosporine, which inhibits the opening of mitochondrial permeability-transition pores, attenuates myocardial reperfusion injury that occurs at the time of reperfusion. In this study, we are seeking to determine whether the administration of cyclosporine at the time of thrombolytic therapy reduces the rate of reperfusion injury during acute anterior STEMI. We will randomly assign 100 patients who will present with acute anterior ST-elevation myocardial infarction to receive either an intravenous bolus of 2.5 mg of cyclosporine per kilogram of body weight (cyclosporine group) or normal saline (control group) immediately before receiving thrombolytic therapy. First day and before discharge LVEF, signs and symptoms of Heart Failure, arrhythmia and in hospital and 6 months mortality will be assessed in all patients and compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807052474N2
Registration date:2010-01-09, 1388/10/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-01-09, 1388/10/19
Registrant information
Name
Mehdi Toluey Khormazard
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1668 6560
Email address
drmtoluey@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice-chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2010-04-21, 1389/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of prethrombolytic Cyclosporine A injection on Acute Anterior ST-Elevation Myocardial Infarction Outcome.
Public title
The Effect of prethrombolytic Cyclosporine A injection on Acute Anterior ST-Elevation Myocardial Infarction Outcome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : in patients with 18 years of age or older, presence of ischemic chest pain and ST segment elevation of 1 mm or more in at least two contiguous leads of anterior region, who admits in primary six hours of symptoms onset and candidate for thrombolytic therapy
Exclusion criteria : cardiac arrest, primary VF, prior MI, uncontrolled HTN, known hypersensitivity to cyclosporine, known renal failure or a serum creatinine level of 120 mol per liter (1.36 mg per deciliter) or more at admission, liver failure, and women who were pregnant or who were of childbearing age and were not using contraception, any disorder that is associated with immunologic dysfunction e.g., cancer, lymphoma, a positive serologic test for the human immunodeficiency virus, or hepatitis
Age
From 20 years old to 85 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Postal code
Approval date
1387-12-05, 769/01/-835
Ethics committee reference number
5/4/10181
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21.0
ICD-10 code description
Acute transmural myocardial infarction of anterior wall
Primary outcomes
1
Description
LVEF
Timepoint
1st day & predischarge
Method of measurement
echocardiography
2
Description
Incidence of Heart Failure
Timepoint
During admission
Method of measurement
Basal pulmonary rales , lasix using, chest XRAY
3
Description
Incidence of Arrhythmia
Timepoint
During admission
Method of measurement
ECG monitoring
Secondary outcomes
1
Description
All cause mortality rate
Timepoint
in hospital & 6 month later
Method of measurement
patient documents & calling
Intervention groups
1
Description
Cyclosporine 2.5 mg/kg in intervention group (pre thrombolytic)
Category
Treatment - Drugs
2
Description
Normal saline in control group (pre thrombolytic)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Heart Center
Full name of responsible person
Dr Mehdi Toluey Khormazard
Street address
Daneshgahe Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice-chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Dr Rasool Azarafarin
Street address
Daneshgahe Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice-chancellor of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mehdi Toluey Khormazard
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Shahid Madani Heart Center, Daneshgah Ave.
City
Tabriz
Postal code
Phone
+98 914 301 8779
Fax
Email
drmtoluey@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Samad Ghaffari
Position
Interventional cardiologist
Other areas of specialty/work
Street address
Shahid Madani Heart Center
City
Tabriz
Postal code
Phone
+98 914 313 7973
Fax
Email
ghafaris@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mehdi Toluey Khormazard
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Shahid Madani Heart Center
City
Tabriz
Postal code
Phone
Fax
Email
drmtoluey@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)