Evaluation the effects of vasodilator (nitroglycerin-TNG) in Cardioplegic Solution myocardial ischemia in patients treated with coronary artery bypass graft surgery in Chamran Hospital, Isfahan
Specific goals
1.Determination of serum troponin I changes before and after surgery in TNG and placebo groups
2.Determination of serum CK-MB changes before and after surgery in TNG and placebo groups
3.Determining the relationship between serum troponin I level before and after surgery in TNG and placebo groups with the number of grafts performed
Design
Clinical trial of control and intervention group and three randomized blind phases of phase 1-2 were performed on 44 patients
Settings and conduct
Operating room for patients with coronary artery bypass graft surgery with the addition of nitroglycerin to the cardioplegia solution, which is blinded on three sides and controlled by troponin and cpk tests before and after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1) Consent of people to participate in the study; patients with coronary artery disease who will undergo CABG
2) EF more than 40%
3) Age between 35 to 70 years
4) Patients who are candidates for non-emergency surgery
Intervention groups
After obtaining written consent from patients, information about age, sex, medical history will be recorded and patients will be randomly divided into two groups receiving nitroglycerin and placebo. All individuals will be given information about the study protocol and moral approval will be obtained from Isfahan University of Medical Sciences for the study. All patients are advised to stop taking aspirin 7 days before surgery. Both groups of troponin I and CPK-MB samples will be checked before surgery.
Main outcome variables
Decreased ischemia, reperfusion in patients undergoing heart surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211225053517N1
Registration date:2022-02-11, 1400/11/22
Registration timing:registered_while_recruiting
Last update:2022-02-11, 1400/11/22
Update count:0
Registration date
2022-02-11, 1400/11/22
Registrant information
Name
fatemeh amiridehnavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 8614
Email address
amirif319@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of vasodilator (nitroglycerin-TNG) in Cardioplegic Solution myocardial ischemia in patients treated with coronary artery bypass graft surgery in Chamran Hospital, Isfahan
Public title
Evaluation the effects of vasodilator (nitroglycerin-TNG) in Cardioplegic Solution myocardial ischemia in patients treated with coronary artery bypass graft surgery in Chamran Hospital, Isfahan
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
In this study, patients with Serener's disease who will undergo CABG.
EF more than 40%
Age between 35 and 70 years
Candidates for non-emergency surgery
Pump time between one to two hours
Arrest time between 30 -100 minutes
Exclusion criteria:
Patients in cardiogenic shock and patients receiving known antioxidants such as captopril mannitol or allopurinol will be excluded from the study.
Also unpredictable events that disrupt the normal surgical process, such as the use of an intra-aortic pump balloon and ECMO, cardiac arrest,
The length of stay in the ICU for more than five days will result in the removal of the sample.
Age
From 35 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method is a simple individual randomization method that was performed using SPSS statistical software and blind three-way.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Lack of information of the participant evaluating the outcome and analyzing the data
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
No 110 Dastgerd Street, Shahid Safarian 2
City
Esfahan
Province
Isfehan
Postal code
8174854511
Approval date
2021-12-26, 1400/10/05
Ethics committee reference number
IR.MUI.MED.REC.1400.497
Health conditions studied
1
Description of health condition studied
Cardiovascular surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Evaluation of changes in troponin and CPK in patients undergoing open heart surgery with nitroglycerin effect
Timepoint
Measurement of troponin and CPK before and after surgery
Method of measurement
Vidas device for troponin check and BT3000 device for CPK check
Secondary outcomes
empty
Intervention groups
1
Description
Addition of injectable nitroglycerin to weight-based cardioplegia solution
Category
Other
2
Description
Control group: Nitroglycerin-free cardioplegia solution
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Dr. Seyed Alireza Hosseini
Street address
Salman Farsi St., Shahid Chamran Hospital
City
Esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Fax
Email
chmrn-dabirkhaneh@mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Alireza Hosseini
Street address
Azadi Square, Hezar Jerib Street
City
Esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
chmrn-dabikhaneh@mui.ca.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
Fatemeh Amiri
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 110 Dastgerd St., Shahid Safarian Alley, 2 dead end,
City
Esfahan
Province
Isfehan
Postal code
8174854511
Phone
+98 31 3776 8614
Email
amirif319@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Alireza Hosseini
Position
surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahid Chamran Hospital
City
Esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
hosseiny@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Alireza Hosseini
Position
heart surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Mushtaq St., Shahid Chamran Hospital
City
esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
hosseiny@med.mui.ac.ir
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
The result of the clinical trial will be published after the thesis is approved
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researcher working in academic and scientific institutions
Under which criteria data/document could be used
For use in future studies
From where data/document is obtainable
Fatemeh Amiri Dehnavi
What processes are involved for a request to access data/document
Refer to the database of Isfahan University, thesis section