Determine the effect of Ischemic preconditioning on myocardial protection in patients undergoing coronary artery bypass graft surgery
Design
In this study, 150 patients were assigned to three groups: control and perfusion and IPC.
Settings and conduct
In this clinical trial, all patients who undergo surgery in Ayatollah Rouhani Hospital Babol with Coronary atherosclerosis diagnosis include the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 50-70; All patients with atherosclerosis underwent coronary artery bypass graft surgery; No redo cardiac operation. Excluction criteria: Concomitant operation; Emergency surgery; Reoperation
Intervention groups
Intervention: Patients are divided in 3 groups: in first group, coronary perfusion with controlled perfusion perssure is applied, in second group we use intermittent clamping and de-clamping (each for 1 minute in three times), and in third group, we use both methods together simultaneously.
Main outcome variables
Main outcome measures: cardiac enzymes, oxidative stress markers and ejection fraction will be measured after operation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161021030410N3
Registration date:2020-06-06, 1399/03/17
Registration timing:registered_while_recruiting
Last update:2020-06-06, 1399/03/17
Update count:0
Registration date
2020-06-06, 1399/03/17
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
2020-01-20, 1398/10/30
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Ischemic preconditioning on myocardial protection in patients undergoing coronary artery bypass graft surgery
Public title
The effect of ischemic preconditioning on myocardial protection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 50-70
All patients with atherosclerosis underwent coronary artery bypass graft surgery
No redo cardiac operation
Exclusion criteria:
Concomitant operation
Emergency surgery
Reoperation
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
Samples will be divided into Three groups using Permuted Block Randomization. Number will be selected for allocation concealment by one of the colleagues and by another, that assignment chain is chosen.
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
2019-12-31, 1398/10/10
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.287
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
Cardiac Enzyme : Creatine Phosphokinase
Timepoint
Before operation, immediatelly after operation, 6 hours after operation, 12 hours after operation and 24 hours after operation
Method of measurement
Serology
2
Description
Oxidative Stress Enzymes
Timepoint
Before operation, immediatelly after operation, 6 hours after operation, 12 hours after operation and 24 hours after operation
Method of measurement
Blood Analyses
3
Description
Ejection Fraction of the Heart
Timepoint
Before and 7 days after operation
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In the 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.
Category
Prevention
2
Description
Intervention group: In second group three repetitive episodes of 1 min ischemia separated by 1 min of reperfusion (at systemic pressure) will be applied on coronary artery Then the clamp will be released completely.
Category
Prevention
3
Description
Intervention group: In third group, controlled perfusion pressure and post conditioning will be applied together during reperfusion of coronary artery.
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?
Yes
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. Saead Alborzi
Position
Resident
Latest degree
Medical doctor
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
Email
saead_alborzi@yahoo.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
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
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
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
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
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
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