To evaluate the effect of selenium 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
Design
Randomized Control Trials, Double blind
Settings and conduct
This is a prospective, randomized controlled trial on a total of 100 consented patients older than 18 years with angioplasty who attended the Shahid Madani clinic of Tabriz University of Medical Science.In selenium group, all patients will be received 1000 microgram selenase IV in normal salin serum half an hour before of angioplasty. The control group will be received only normal salin serum (pelacebo). Biochemical markers will be checked level 12 hours before, 8, and 24 hours after PCI in each groups.
Participants/Inclusion and exclusion criteria
Inclusion: Ischemic heart diseases and diabetic patients; age 18-85; undergoing of angioplasty with stent insertion; filling of consent form
ٍExclusion: 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 groups
intervention group will recieve 1000 microgram selenium dose with standard treatments control group will only recieve standard treatments and placebo
Main outcome variables
Primary outcomes: Change of CK-MB and cTnI level 12 hours before, 8, and 24 hours after PCI in each groups
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20111206008307N30
Registration date:2018-12-27, 1397/10/06
Registration timing:registered_while_recruiting
Last update:2018-12-27, 1397/10/06
Update count:0
Registration date
2018-12-27, 1397/10/06
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
2018-09-23, 1397/07/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized trial of selenium in the prevention of pre-procedural myocardial injury in patients undergoing angioplasty
Public title
selenium in the prevention of pre-procedural myocardial injury in patients undergoing angioplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ischemic heart diseases and diabetic patients; age 18-85; 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
Used
Assignment
Parallel
Other design features
Randomization will be performed using permuted block randomization with a block size of 2 and an allocation ratio of 1:1 in two groups of Selenium and control.
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
Province
East Azarbaijan
Postal code
-
Approval date
2018-08-21, 1397/05/30
Ethics committee reference number
tbzmed.rec.1397.433
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
Intervention group: intervention group will recieve 1000 microgram selenium dose with standard treatments control group will only recieve standard treatments and placebo
Category
Treatment - Drugs
2
Description
Control group: In the control group, patients only will be given the standard treatment.
Category
N/A
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
-
Phone
+98 41 3339 2593
Fax
Email
tentezari@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Faculty of pharmacy, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
-
Email
tentezari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
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
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 413344798
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
Dr. Taher Entezari-maleki
Position
Assistant professor/ Clinical pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 41 3339 2593
Email
tentezari@gmail.com
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
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 413392593
Email
tentezari@gmail.com
Sharing plan
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
Not applicable
Title and more details about the data/document
Selenase in PMI
When the data will become available and for how long
After article publishing about 2 years after.
To whom data/document is available
All data of article.
Under which criteria data/document could be used
Based on publisher permission
From where data/document is obtainable
Based on publisher permission or may open access policy
What processes are involved for a request to access data/document
Permission from corresponding or purchase the article or open access policy