Determine the effect of Ischemic postconditioning on myocardial protection in patients undergoing coronary artery bypass graft surgery
Design
A randomized parallel control group, open-label, phase 2 clinical trial
Settings and conduct
The study population is patients with an age range of 50 to 70 years With coronary atherosclerosis Candidate for CABG referred to Ayatollah Rouhani Hospital in Babol.After the initial assessment and Having entry conditions, They are randomly divided into three groups. before weaning from the pump, In IPost group repetitive brief episodes of opening and occluding the vascular grafts, In perfusion group,12 minutes after releasing the partial aortic clamp without occluding any vascular graft. in control group,weaning was done immediately after releasing the partial aortic clamp. After surgery,serum CPK-MB level will be measured
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 50-70, All patients with atherosclerosis are candidates for coronary artery bypass graft surgery, No redo cardiac operation, serum CPK of MB level less than 20, Receive informed consent
Exclusion criteria: Underlying diseases such as kidney disorders, liver disorders
Intervention groups
Patients are divided into three groups. In IPost group and before weaning from the pump, repetitive brief episodes of opening and occluding the vascular grafts were created using bulldog clamp. Each episode was 3 minutes long and the entire process lasted 12 minutes. In the perfusion group, weaning was done 12 minutes after releasing the partial aortic clamp without occluding any vascular graft. Lastly in the control group, weaning was done immediately after releasing the partial aortic clamp
Main outcome variables
serum CPK-MB level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161021030410N4
Registration date:2021-09-09, 1400/06/18
Registration timing:registered_while_recruiting
Last update:2021-09-09, 1400/06/18
Update count:0
Registration date
2021-09-09, 1400/06/18
Registrant information
Name
Ghasem Faghanzadeh Ganji
Name of organization / entity
Babol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8308
Email address
gh.faghanzadeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-05, 1400/06/14
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Ischemic postconditioning on myocardial protection in patients undergoing coronary artery bypass graft surgery
Public title
The effect of ischemic postconditioning on myocardial protection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 50-70
Serum CPK levels of MB less than 20 before surgery
All patients with atherosclerosis are candidates for coronary artery bypass graft surgery
No redo cardiac operation
Receive informed consent
Exclusion criteria:
Underlying diseases such as kidney disorders, liver disorders
Age
From 50 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly divided into 3 groups of 50 subjects with six blocks and an allocation ratio of 1:1:1. The participants allocation sequence in three groups perform with a Randomizer software. Opaque sealed sequentially numbered envelops use for allocation concealment.
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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Approval date
2020-04-04, 1399/01/16
Ethics committee reference number
IR.MUBABOL.REC.1399.006
Health conditions studied
1
Description of health condition studied
Cardiovascular Disease
ICD-10 code
I51.6
ICD-10 code description
Cardiovascular Disease, Unspecified
Primary outcomes
1
Description
CPK-MB Enzyme
Timepoint
Before operation, immediatelly after operation, 6 hours after operation, 12 hours after operation and 24 hours after operation
Method of measurement
Serology
Secondary outcomes
empty
Intervention groups
1
Description
Control group: routine after heparin and cannulation of the aorta and right atrium and start the pump, aortic clamping and injection cardioplegin the aortic root and inducing arrest of the heart, anastomosis distal to the vascular coronary and after turning clamp of perfect for the partial, proximal anastomosis will be performed.In this group, immediately after removing the partial aortic clamp, the pump will be removed.
Category
Prevention
2
Description
Intervention group: In perfusion group, 12 minutes after removal of the aortic partial clamp exits the pump without vascular grafts close by bulldog.
Category
Prevention
3
Description
Intervention group: In Ipost group before leaving the pump, 3 minutes after removal of the aortic partial clamp, vascular grafts are closed by bulldogs for 3 minutes. again reopen these bulldogs for three minutes and close again for another 3 minutes (overall for 12 minutes after removing the aortic partial clamp) bulldogs are removed. then patient exits of pump.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Ayatollah Rouhani Hospital
Full name of responsible person
Dr. Ghasem Faghanzadeh Ganji
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8301
Fax
+98 11 3223 8309
Email
ghf.ganji@gmail.com
Web page address
http://www.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Ghasem Faghanzadeh Ganji
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8301
Fax
+98 11 3223 8309
Email
ghf.ganji@gmail.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Ghasem Faghanzadeh Ganji
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8301
Fax
+98 11 3223 8309
Email
ghf.ganji@gmail.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Ghasem Faghanzadeh Ganji
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8301
Fax
+98 11 3223 8309
Email
ghf.ganji@gmail.com
Web page address
http://www.mubabol.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD