The Comparison of the effect of Antegrade and Antegrade-Retrograde blood cardioplegia approach on paradoxical septal motion after coronary artery bypass graft
The comparison of the effect of antegrade and antegrade-retrograde blood cardioplegia approach on paradoxical septal motion after heart surgery.
Design
A clinical trial with two groups of 36 people comparing the effects of two methods: three way blinded ،randomized with coin tossing
Settings and conduct
This study is performed in patients referred to Isfahan Chamran Hospital. The cannula is implanted by a heart surgeon. The cardioplegia solution is injected by a perfusionist with pressure control. It is performed after surgery and before discharge echocardiography . The paradoxical septum is examined, and patients and the evaluator of the effect of the intervention and the data analyzer did not know in which group the samples were.
Participants/Inclusion and exclusion criteria
1. Being 45 to 65 years old
2-EF more than 50 precent in preoperative echocardiography
3. No septal movement disorder in preoperative echocardiography
4. No history of myocardial infarction
5. No aortic valve insufficiency in preoperative echocardiography
6. Lack of internal heart pacemaker
Intervention groups
Patients who are candidates for coronary artery bypass graft surgery in terms of cardioplegia method are divided into two groups: antegrade, which is implanted in the aortic root, and antegrade-retrograde group, which is injected in both the aortic root and coronary sinus in reverse anatomical blood flow of cardioplegia solution. .
Main outcome variables
The measurable variable is the paradoxical septal motion, which is a measure of the lack of proper cardiac protection during surgery.
General information
Reason for update
Acronym
psm
IRCT registration information
IRCT registration number:IRCT20170620034666N5
Registration date:2022-03-16, 1400/12/25
Registration timing:retrospective
Last update:2022-03-16, 1400/12/25
Update count:0
Registration date
2022-03-16, 1400/12/25
Registrant information
Name
Mehran Shahzamani
Name of organization / entity
Isfahan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 3670 1227
Email address
m.shahzamani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
2021-06-05, 1400/03/15
Actual recruitment end date
2022-01-05, 1400/10/15
Trial completion date
2022-01-15, 1400/10/25
Scientific title
The Comparison of the effect of Antegrade and Antegrade-Retrograde blood cardioplegia approach on paradoxical septal motion after coronary artery bypass graft
Public title
The effect of cardioplegia on paradoxical septal motion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being 45 to 65 years old
EF more than 50% in preoperative echocardiography
No septal movement disorder in preoperative echocardiography
No history of myocardial infarction
No aortic valve insufficiency in preoperative echocardiography
Lack of internal heart pacemaker
No absence of right or left branch block in the ECG after cardiac surgery
Absence of intraventricular conduction delay (IVCD) in preoperative ECG
Exclusion criteria:
The unwillingness of the patient or companions to participate in the study
Existence of shunt inside the heart
The presence of right and left branch blocks in the ECG before surgery
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The simple randomization method was performed by tossing coins between the samples that met the inclusion criteria, considering that there were two groups in the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The samples did not know the type of implantation of the cardioplegia cannula
Caregivers did not know how to insert a cardioplegia cannula
The echocardiographer did not know the surgical procedure and the type of cannula implantation
Placebo
Not used
Assignment
Parallel
Other design features
This study is performed on two groups and each group has 36 people. In one group, cardioplegia was injected as antegrade and in the other group as antegrade-retrograde and its effects were compared.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences - Committee on Research Ethics
Street address
Hezar jerib st esfahan university of medical sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-09-20, 1400/06/29
Ethics committee reference number
IR.MUI.MED.REC.1400.496
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
T82.21
ICD-10 code description
Mechanical complication of coronary artery bypass graft
Primary outcomes
1
Description
Paradoxical septal motion
Timepoint
Post surgery
Method of measurement
Echocardiography in M mode
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In one group, cardioplegia cannula is inserted by the surgeon in the root of the aorta and the perfusionist injects the cardioplegia through the heart and lung pump.After surgery and before discharge,paradoxical motion of the septum, which is a measure of myocardial protection, are examined by echocardiography.
Category
Diagnosis
2
Description
Intervention group: In the other group, the cardioplegia solution is injected both in the aortic root and through the coronary sinus, which is implanted by a surgeon with a special device, by a perfusionist through a heart and lung pump as in the previous group, and after surgery and before discharge paradoxical motion of The septum is identified by echocardiography.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Dr mehran shahzamani
Street address
Salman farsi BlvTchamran hospital
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
M.shahzamani@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Research department of Isfahan University of Medical Sciences
Street address
Hezar jerib st,esfahan university of medical science
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
M.shahzamanin@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr mehran shahzamani
Position
Specialist in cardiovascular surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Hezar jerib st,esfahan university of medical sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
031-3668048
Email
M.shahzamani@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr mehran shahzamani
Position
Specialist in cardiovascular surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Hezar jerib st esfahan university of medical sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Alij1367@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr mehran shahzamani
Position
ُُSpecialist in cardiovascular surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Hezar jerib st esfahan university of medical sciences
City
ٍEsfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Alij1367@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
En After finishing the study the data will be available
When the data will become available and for how long
After publishing the article
To whom data/document is available
faculty members
Under which criteria data/document could be used
Contacting the scientist responsible by email causes the data to be used in order to use the data in scientific research such as meta-analysis or secondary analysis.
From where data/document is obtainable
Scientific responsible can provide the study data to academic researchers without the name of individuals. Scientific responsible: Dr.mehran shahzamani. Address: Isfahan. Moshtagh Ave, chanran heart center. postal code: (8174673461). Call number: (+98 31 3670 1227). Mobile phone number: (+98 913 123 1453). Email: m.shahzamani@med.mui.ac.ir
What processes are involved for a request to access data/document
Just forwarding email to scientific responsible of this trial is enough. Email address: m.shahzamani@med.mui.ac.ir (Will be answered within a month.)