Protocol summary

Summary
Objective: Some degree of cardiac ischemia is seen in cardiac operation due to the decrease in coronary blood flow and re-perfusion injury. Myocadial infarction and decreased cardiac output are the main results of these injuries. In order to control the severity of these injuries, we will use a new type of conditioning strategy namely ischemic post conditioning in our study. Setting and conduct: Patients included in study are candidate for CABG, all will be undergoing cardiopulmonary. Then the aortic cross clamp will be applied and heart will be stopped. After completion of operation and just before releasing of cross clamp, coronary blood flow will be reestablished in three ways: controlled perfusion pressure, post conditioning and simultaneous technique. Inclusion criteria: Age 50-70; Left Ventricular EF more than 40 percent; Complete occlusion of LAD; No redo cardiac operation. Excluction criteria: Concomitant operation; Aortic clamp time more than 100 minute; Cardiopulmonary bypass time more than 130 minute 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 measures: cardiac enzymes, oxidative stress markers and ejection fraction will be measured after operation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014121520324N1
Registration date: 2015-02-07, 1393/11/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-07, 1393/11/18
Registrant information
Name
Naser Safaie
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 0894
Email address
safaien@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Scinces
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of ischemic postconditioning and controlled aortic root reperfusion on myocardial protection in CABG surgery with cardiopulmonary bypass
Public title
The effect of ischemic postconditioning on myocardial protection
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Age 50-70 years old; Ejection fraction more than 40 percent; Complete occlusion of LAD; No redo cardiac operation Excluction criteria: concomitant operation; aortic clamp time more than 100 minute; CPB time more than 130 minute
Age
From 50 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Scinses
Street address
Daneshgah street
City
Tabriz
Postal code
Approval date
2014-10-09, 1393/07/17
Ethics committee reference number
93109

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
Ejection Fraction
Timepoint
Before and 7 days after operation
Method of measurement
Echocardiography

2

Description
Cardiac dysrhythmia
Timepoint
After operation for 72 hours
Method of measurement
Cardiac monitoring and Electrocardiography

3

Description
oxidative stress enzymes
Timepoint
before starting of operation, Before starting coronary reperfusion, ten minute after reperfusion, 1st, 2nd, and 3rd days after operation
Method of measurement
Blood analyses

4

Description
Cardiac Enzymes
Timepoint
Before starting the operation, before starting coronary reperfusion, ten minute after reperfusion, 1st, 2nd, and 3rd days after operation
Method of measurement
biochemical analyses of blood

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
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

2

Description
In third group, controlled perfusion pressure and post conditioning will be applied together during reperfusion of coronary artery.
Category
Prevention

3

Description
All patients will undergo CABG operation with CPB assisted protocol, which will be conducted using a membrane oxygenator. Non pulsatile pump blood flow will be set at 2.4 times of body surface area and the body core temperature will be allowed to decline to 32 ◦c. In this setting, the cardioplegia solution is delivered via antegade and retrograde routes for 4 minute with 150 ml.m2.min after aortic cross-clamp and repeated every 20 minutes. At the end of procedure and just before cross-clamp removal, reperfusion will be started in three groups as following: In first group, the coronary perfusion with controlled perfusion pressure of root aorta (30 mm Hg in first 3 minutes and then 50 mm Hg for last 7 minutes) will be applied.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Heart Hospital
Full name of responsible person
Naser Safaie
Street address
Shahid Madani Heart Hospital, Daneshgah street
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Tabriz University of Medical Sciences, Daneshgah Street
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Ali Sheikhalizadeh
Position
Bachelor of Scinence in Nursing and physiology Msc Student
Other areas of specialty/work
Street address
Shahid Madani Heart Hospital, Daneshgah Street
City
Tabriz
Postal code
5166615573
Phone
+98 41 3336 0894
Fax
+98 41 3337 3919
Email
seikhali@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences, Department of Physiology
Full name of responsible person
Reza Badalzadeh
Position
Ph.D
Other areas of specialty/work
Street address
Faculty of medicine, Daneshgah Street
City
Tabriz
Postal code
Phone
+98 41 3336 4664
Fax
+98 41 3336 4664
Email
badalzadehr@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Ali Sheikhalizadeh
Position
Bachelor of Scinence in Nursing and physiology Msc Student
Other areas of specialty/work
Street address
Shahid Madani Heart Hospital, Daneshgah Street
City
Tabriz
Postal code
5166615573
Phone
+98 41 3336 0894
Fax
+98 41 3337 3919
Email
seikhali@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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