Protocol summary

Summary
Objective: To evaluate the effect of allopurinol on cardiac pre-procedural injury in patients undergoing angioplasty. Design: A prospective, single blinded, randomized controlled trial on patients with ischemic heart diseases who undergoing angioplasty. Setting and conduct: All patients with ischemic heart diseases who undergoing angioplasty in Shahid Madani Hospital will be randomized (using permuted block randomization, block size 2, allocation ratio 1:1) in two groups of allopurinol treated (n=50) and control (n=50). Participants: All consented patients with ischemic heart diseases aged 18-80 who undergoing angioplasty and stent insertion. The exclusion criteria will include elevation of CK-MB and cTnI before PCI, history of CABG during last three months, history of previous MI, renal dysfunction (creatinine above 2.5 mg/dl), unsuccessful PCI, acute MI, cardiogenic shock, dialysis, pregnancy, inability in filling and understanding of the consent form, unconsented patients, patients who want to discontinue the study at any time. Intervention: In allopurinol group, all patients will be received totally 1200 mg of oral allopurinol before PCI plus standard treatment. The control group will be received only standard treatment. Primary outcomes: Change of CK-MB and cTnI level 12 hours before, 8, and 24 hours after PCI in each groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201412088307N11
Registration date: 2017-07-04, 1396/04/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-04, 1396/04/13
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
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-10-02, 1393/07/10
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized trial of allopurinol in the prevention of pre-procedural myocardial injury in patients undergoing angioplasty
Public title
Allopurinol in the prevention of pre-procedural myocardial injury following angioplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Ischemic heart diseases patients; age 18-80; undergoing of angioplasty with stent insertion; filling of consent form. Exclusion Criteria: Elevation of CK-MB and cTnI before PCI; history of CABG during last three months; history of previous MI; renal dysfunction (creatinine above 2.5 mg/dl); unsuccessful PCI; acute MI; cardiogenic shock; dialysis; pregnancy; inability in filling and understanding of the consent form; unconsented patients; patients who want to discontinue the study at any time
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
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
Committee on Medical Ethics of Tabriz University of Medical Sciences
Street address
Golgasht Street
City
Tabriz
Postal code
-
Approval date
2014-09-29, 1393/07/07
Ethics committee reference number
93102

Health conditions studied

1

Description of health condition studied
Ischemic heart diseases patients
ICD-10 code
I20, I21,
ICD-10 code description
Ischaemic heart diseases

Primary outcomes

1

Description
CK-MB level
Timepoint
12 hours Before, 8 and 24 hours after angioplasty
Method of measurement
ELISA

2

Description
cTnI level
Timepoint
Before, 8 and 24 hours after angioplasty
Method of measurement
ELISA

Secondary outcomes

empty

Intervention groups

1

Description
Control: In the control group, patients only will be given the standard treatment.
Category
N/A

2

Description
Intervention: In allopurinol group, all patients will be received totally 1200 mg before PCI plus the standard treatment.
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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Faculty of pharmacy, Daneshgah Street
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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. Taher Entezari-Maleki
Position
Assistant professor/ Clinical pharmacist
Other areas of specialty/work
Street address
Daneshghah Street
City
Tabriz
Postal code
-
Phone
+98 41 3339 2593
Fax
-
Email
tentezari@gmail.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari-Maleki
Position
Assistant professor/ Clinical pharmacist
Other areas of specialty/work
Street address
Daneshgah street
City
Tabriz
Postal code
-
Phone
+98 41 3339 2593
Fax
-
Email
tentezari@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
Taher Entezari-Maleki
Position
Assistant professor/ Clinical pharmacist
Other areas of specialty/work
Street address
Daneshgah street
City
Tabriz
Postal code
-
Phone
+98 413392593
Fax
-
Email
tentezari@gmail.com
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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