Evaluation Effects of Allopurinol on Plasma Level of Cardiac Troponin I and CK-MB Enzyme in ischemic heart patients.
Design
Randomised controlled clinical trial, Not blinded
Settings and conduct
This study is performed as a randomized clinical trial on 100 patients aged 18-80 years who have completed the ethical consent form and have been admitted to the emergency room of the Shahid Madani Research and Treatment Center in Tabriz with the diagnosis of acute coronary syndrome.
In addition to routine treatment, patients in the intervention group receive allopurinol from Hakim Pharmaceutical Company.Patients in the control group receive only routine treatment. Blood levels of cardiac creatine kinase and cardiac troponin I in both groups are checked by ELISA.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with acute ischemic heart syndrome and 18-80 years old who have completed the form of ethical consent. Exclusion criteria: Serum creatinine above 2 mg per deciliter, unstable angina, persistent angina, history of dialysis and cardiogenic shock.
Intervention groups
Intervention group: In addition to routine treatment, patients receive oral administration of 600 mg of allopurinol Product of Hakim Pharmaceutical factory in two divided doses on the first day and then 300 mg of allopurinol daily for four days. Control group: will receive only routine treatment.
Main outcome variables
CTnI and CK-MB enzyme
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111206008307N36
Registration date:2020-07-28, 1399/05/07
Registration timing:retrospective
Last update:2020-07-28, 1399/05/07
Update count:0
Registration date
2020-07-28, 1399/05/07
Registrant information
Name
Taher Entezari-Maleki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
tentezarimaleki@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Allopurinol effect on Plasma Level of Cardiac Troponin-I and Creatine Kinase- MB in acute ischemic heart disease (ACS)
Public title
Evaluation of the effect of Allopurinol in reducing heart damage in acute ischemic heart patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with acute ischemic heart syndrome
Age 80-18 years
Ability to understand and sign consent forms
Exclusion criteria:
Serum creatinine above 2 milligram Per deciliter
Acute myocardial infraction
History of dialysis
Cardiogenic shock
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization was performed based on computer-generated random numbers list using online Graphpad randomizer software (https://www.graphpad.com/quickcalcs/randMenu/) and an allocation ratio of 1:1 in two intervention (group A) and control (Group B) with sample size n=100. After randomization 50 patients allocated in group A and the other 50 patients allocated in group B.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Reasearch and Technology Deputy, Tabriz University of Medical Science, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-07-18, 1398/04/27
Ethics committee reference number
TBZMED.REC.1398.424
Health conditions studied
1
Description of health condition studied
Acute cardiac ischemic patients
ICD-10 code
I21.4
ICD-10 code description
Non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Cardiac troponin I
Timepoint
Before, 8, 16, 24 and 32 hours after receiving allopurinol
Method of measurement
ELISA kits
2
Description
Creatine Kinase-MB
Timepoint
Before, 8, 16, 24 and 32 hours after receiving allopurinol
Method of measurement
ELISA kite
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After diagnosis of ischemic heart disease, patients receive 600 mg of allopurinol, product of Hakim Pharmaceutical factory, in two divided doses on the first day and then 300 mg of allopurinol daily for 4 days.Then the blood levels of cTnI and CK-MB are checked every 8 hours for 5 times by ELISA.
Category
Treatment - Drugs
2
Description
Control group: Patients receive routine treatment after the diagnosis of ischemic heart disease. Blood levels of the cTnI and CK-MB enzyme are checked every 8 hours for 5 times by ELISA.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Heart Center of Tabriz
Full name of responsible person
Dr. Taher Entezari-Maleki
Street address
Shahid Madani Heart Center, Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 4798
Email
tentezari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghacem Joiban
Street address
Tabriz Universit of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Web page address
https://researchvice.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the data of an article can be published after making patients unrecognized
When the data will become available and for how long
After publishing of article until 6 months after publishing of the results
To whom data/document is available
Data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers that request data will be permitted only to doing analysis according to ethics for scientific aims
From where data/document is obtainable
Applicants can receive data by sending an E-mail to address of tentezari@gmail.com and get response from Dr. Taher Entezari Maleki
What processes are involved for a request to access data/document
After contacting with corresponding author(Dr.Taher Entezari Maleki), data will be sent to Tabriz Shahid Madani hospital ethics committee and after receiving permission, data will be send to applicants