Protocol summary

Study aim
Comparison of the effect of cartidilol and metoprolol on the incidence of AF after cardiac surgery in patients undergoing open heart surgery in Imam Ali Hospital in 1997
Design
To assign people to two groups, randomization is done by blocking method, which each intervention patient receives. As such, 6 blocks of 4 are provided as follows.1) AABB 2) ABAB 3) ABBA 4) BBAA 5) BABA 6) BAAB Block selection is based on the random number table. Group A patients receiving metoprolol and B patient receiving cartidilol.
Settings and conduct
In this study, double blind blindness is used so that the patient and the investigator who applies the interventions are not aware of the interventions. . After transferring patients to the department, monitoring of the 24-hourly electrocardiogram will be performed for five days
Participants/Inclusion and exclusion criteria
. The criteria for entering the study will be all patients who undergo cardiac surgery due to coronary artery disease or valvular abnormalities, preoperative beta-blocker therapy (propranol, metoprolol, cartidilol for heart rate of 60 to 70 Minutes) and obtaining written consent, patients with prior history of atrial fibrillation, receive class I, II antiarrhythmic drugs, digoxin, permanent or temporary pacemakers, each grade from the heart block, bradycardia with heart rate less than 50, end-stage renal disease (ESRD) ), Severe pulmonary disease (pneumonia, COPD) and severe liver disease (cirrhosis or hepatitis folinitis) They will not be included in the study.
Intervention groups
In this randomized clinical trial, patients undergoing non-emergency open heart surgery candidates admitted to Ali ibn Abitaleb Zahedan Hospital will be divided into two groups of metoprolol, cartidilol to prevent the onset of AF.
Main outcome variables
AF incidence in patients after open heart surgery

General information

Reason for update
Acronym
AFCABG
IRCT registration information
IRCT registration number: IRCT20181110041604N1
Registration date: 2019-04-13, 1398/01/24
Registration timing: registered_while_recruiting

Last update: 2019-04-13, 1398/01/24
Update count: 0
Registration date
2019-04-13, 1398/01/24
Registrant information
Name
aylar ghavanjzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3329 4209
Email address
rasoul.ftoomach@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of metoprolol and carvedilol in prevention of AF after CABGS
Public title
The comparison of metoprolol and carvedilol in prevention of AF after CABGS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The criteria for entry into the study will be all patients who undergo cardiac surgery due to coronary artery disease or valvular disorders
Exclusion criteria:
Previous history of atrial fibrillation Receiving class I, II antiarrhythmic drugs Digoxin Permanent or temporary pacemaker Each grade of the heart block - Bradycardia with heart rate less than 50 Dialysis patients Severe pulmonary disease Heavy liver disease
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 170
Randomization (investigator's opinion)
Randomized
Randomization description
To assign people to two groups, randomization is done by blocking method, which each intervention patient receives. As such, 6 blocks of 4 are provided as follows. 1) AABB 2) ABAB 3) ABBA 4) BBAA 5) BABA 6) BAAB Block selection is based on the random number table. Group A patients receiving metoprolol and B patient receiving cartidilol.
Blinding (investigator's opinion)
Double blinded
Blinding description
To assign people to two groups, randomization is done by blocking method, which each intervention is receiving. Patients and physicians are not aware of blind blindness. Block selection is based on the random number table. Group A patients receiving metoprolol and B patient receiving carveidilol.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Imam Ali Hospital ,Khalij Fars Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817959515
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
IR.ZAUMS.REC.1397.250

Health conditions studied

1

Description of health condition studied
AF
ICD-10 code
I48.0
ICD-10 code description
Paroxysmal atrial fibrillation

Primary outcomes

1

Description
AF after surgery
Timepoint
5 days after surgery
Method of measurement
ECG

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients who receive metoral
Category
Treatment - Drugs

2

Description
Intervention group: Patients receiving carvedilol
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali hospital Zahedan
Full name of responsible person
Aylar Ghavanjzade
Street address
Khalije Fars Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817959515
Phone
+98 54 3329 5634
Email
Rasoul.ftoomach@gmil.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Deputy of Research of Zahedan University of Medical Sciences-Dr Shahraki
Street address
Khalij Fars Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817959515
Phone
+98 54 3329 5634
Email
Rasoul.Ftoomach@gmail.com
Web page address
http://Zaums.ac.ir/default.page
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
20
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
Zahedan University of Medical Sciences
Full name of responsible person
Aylar.Ghavanjzade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Khalij Fars Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817959515
Phone
+98 911 523 5760
Email
Rasoul.ftoomach@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Aylar Ghavanjzade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Persian Gulf Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817959515
Phone
+98 54 3329 5637
Email
Rasoul.ftoomach@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Aylar Ghavanjzade
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Khalije Fars blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817959515
Phone
+98 54 3329 5637
Email
Rasoul.ftoomach@gmail.com

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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...