effect of pentoxifylline in ameliorating myocardial injury in patients with anterior myocardial infartion undergoing thrombolytic therapy :randomized controlled trial,a pilot study
The aim of study : Effect of pentoxifylline in ameliorating the myocardial injury in patients with anterior myocardial infartion undergoing thrombolytic therapy . This study will be done in 90 patients with over 18 years old visiting the emergency department of madani heart hospital ,tabriz,iran.this study is a single center randomized controlled trial(a pilot study) .
Inclusion criteria: Patients over 18 old years; Acute myocardial infarction; Undergoing thrombolytic therapy Exclusion criteria: History of coronary arterial bypass graft; History of myocardial infarction; History of renal failure; History of cardiogenic shock Demographic ,clinical,labratory and theraputical data of patients will be collected by study the medical records of patients and history taking .The data will be recorded in spacial form . Patients will be divided to two groups with equal sample size ,intervention group and control group with randomized systematic method .Intervention group will be given 1200 mg loading dose of pentoxiphylline tablet.Control group will not be given placebo.Paraclinical evaluation will be done at hospital labratory. Labratory personnels will be blind about patients group. Primary end point:
Cardiac enzymes will be checked once at base and every 8 hour during 48 hour of hospitalization.Then mean and peak of cardiac enzymes will be calculated. Secondary end point:
The rate of ST-resolution at 90 minute will be compared between tow group .Then the patients will be followed up for one month, and the data about reangina,reinfarction ,rehospitalization , cardiac mortality and all cause mortality will be collected.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015102624722N1
Registration date:2016-01-17, 1394/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Rasol Zohouri
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41333801090
Email address
zohourir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Cardiovascular Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-15, 1394/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of pentoxifylline in ameliorating myocardial injury in patients with anterior myocardial infartion undergoing thrombolytic therapy :randomized controlled trial,a pilot study
Public title
Effect of pentoxifylline in myocardial infartion
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
patients with over 18 year; patients with acute anterior myocardial infarction; patients undergoing thrombolytic therapy exclusion criteria: history of coronary artery by pass graft; history of myocardial infarction; history of renal failure; sensitivity to aspirin,clopidogrel or pentoxifylline; cardiogenic shock
Age
From 18 years old to 139 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randumized Numeral Table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Medical Sciences
Street address
Tabriz University Of Medical Sciences, Gholghasht Street
City
Tabriz
Postal code
Approval date
2015-05-28, 1394/03/07
Ethics committee reference number
5/4/2394 کد اخلاقیTBZMED.REC.1394.173
Health conditions studied
1
Description of health condition studied
myocardial infarction
ICD-10 code
IX
ICD-10 code description
Diseases of the circulatory ystem
Primary outcomes
1
Description
check of cardiac enzymes(cpk ,CK-MB)
Timepoint
check at base then every 8 hour until 48 hour
Method of measurement
Enzymes chec
Secondary outcomes
1
Description
the st-resolution rate at 90 minute after given thrombolytic
Timepoint
90 minute after given thrombolytic
Method of measurement
percent of st decline
Intervention groups
1
Description
Intervention group:1200 mg loading dose of pentoxiphylline table(3 tablet 400 mg )trance oral without continuous Hakim Manufactory
Category
Treatment - Drugs
2
Description
control group:no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Educational,Theraputical And Research Center
Full name of responsible person
Rasol Zohouri
Street address
Madani Educational,Theraputical And research Center, University Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cardiovascular Research Center, Tabriz University Of Medical Sciences
Full name of responsible person
Dr Hossin Namdar
Street address
Cardiovascular Research Center, Shahid Madani Heart Hospital, University Street
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cardiovascular Research Center, 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
madani educational,theraputical and research cardiovascular center