Abstract
To study the effect of cyclosporine oral myocardial damage during coronary artery bypass surgery in Golestan HospitalIn the period 2017, 60 patients older than 18 years and below 80 years of age who were undergoing coronary artery bypass surgery and patients without liver or kidney failure or angina And was not using of drugs such as glibenclamide and nicorandil were enrolled and non randomly divided into two groups . aterf signing informed consent 4-12hr before surgery, patients with placebo or orall cyclosporine 2.5 mg per kg is administered. Intraoperative monitoring in patients undergoing cardiac and pressure. To assess the extent of myocardial injury CKMB and troponin I in patients before surgery and at 24, 48 and 72 blood samples taken after surgery. Blood tests also included preoperative hemoglobin, the red blood cell count and white, glomerular filtration hepatic transaminase and bilirubin . All patients before surgery and in the seventh day after the surgery will be performed echocardiography.
General information
Acronym
does not have
IRCT registration information
IRCT registration number:IRCT2017031533056N2
Registration date:2017-06-21, 1396/03/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-21, 1396/03/31
Registrant information
Name
Marzye Dorra
Name of organization / entity
JundiShapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 8037
Email address
dorra.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2017-01-19, 1395/10/30
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Oral cyclosporine effect on myocardial damage heart
Public title
Effect of cyclosporine oral myocardial injury in patients undergoing coronary artery bypass surgery hospital in Ahvaz Golestan second half of 2017: a randomized controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- All patients who undergoing coronary artery bypass surgery .
- Patients over 18 years
- willingness to participate in the study
Exclusion criteria
- patients over 85 years
- patients with unstable angina
- Patients with moderate to severe renal impairment (glomerular filtration rate less than mL / min / m2 45)
- developing cirrhosis of the liver
- Oral administration of drugs glibenclamide or nicorandil (due to drug interactions).
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
does not have
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz JundiShapur University of Medical Sciences
Street address
Ethics committee of Ahwaz JundiShapur University of Medical Sciences
City
Ahwaz
Postal code
Approval date
2017-02-07, 1395/11/19
Ethics committee reference number
IR.AJUMS.REC.1395.784
Health conditions studied
1
Description of health condition studied
Myocardial heart
ICD-10 code
151.5
ICD-10 code description
Myocardial degeneration
Primary outcomes
1
Description
Troponin_I
Timepoint
Troponin I measurements before surgery and at 24hr, 48hr and 72hr after surgery
Method of measurement
After preparing the evaluation kit little troponin (cTnI) by Golestan hospital laboratory
Secondary outcomes
1
Description
CKMB
Timepoint
CKMB measurements before surgery and at 24hr, 48hr and 72hr after surgery
Method of measurement
CKMB measurements in the laboratory Golestan Hospital
Intervention groups
1
Description
four to twelve hours before surgery given to patients cyclosporine capsules orally at a dose of 2.5 mg per kg for a single Dose under normal conditions and maitain general anesthesia and monitoring blood pressure and ECG
2- four to twelve hours before surgery given to patients placebo orally for a single Dose under normal conditions and maitain general anesthesia and monitoring blood pressure and ECG
Category
Treatment - Drugs
2
Description
Four to twelve hours before surgery to patients given placebo orally All stages of operation under normal conditions and maintain general anesthesia and monitoring blood pressure and electrocardiogram done
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The training center - Golestan hospital-Heart surgery
Full name of responsible person
Marzye Dorra
Street address
Cui Golestan - Golestan Hospital
City
ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Development Jundishapur University of Medical Sciences
Full name of responsible person
Doctor Behzad Sharif Makhmal zadeh
Street address
Ahwaz University Department of Research and Technology Development
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology Development Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahwaz JundiShapur University of Medical Sciences
Full name of responsible person
Seyed Mohammad hassan Adel
Position
Professor of Cardiology
Other areas of specialty/work
Street address
Golestan quarter-Imam Khomeini (RA) Ahvaz - Department of Cardiology
City
Ahwaz
Postal code
Phone
+98 61 3222 8037
Fax
Email
Dr.hassan.adel@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz JundiShapur University of Medical Sciences
Full name of responsible person
Mohammad ali Sheikhi
Position
Cardiovascular Surgery
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital Department of Cardiac Surgery
City
Ahwaz
Postal code
Phone
+98 61 3374 3036
Fax
Email
sheikhi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz JundiShapur University of Medical Sciences
Full name of responsible person
Marzye Dorra
Position
Student
Other areas of specialty/work
Street address
The training center - Golestan hospital
City
Ahwaz
Postal code
Phone
+98 61 3374 3036
Fax
Email
drmarzyedorra@gmail.comdorra.m@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)