Objective: The purpose of this study is to evaluate the effect of periaortic fat pad removal during coronary artery bypass grafting on the autonomic nervous system tone, incidence of postoperative atrial fibrillation, length of hospital stay, in-hospital morbidity and mortality.
Inclusion and exclusion criteria:
Patients who scheduled to undergo their first coronary artery bypass grafting aged 35-75 will be included. Patients will be excluded if; a) have repeated CABG, b) have concomitant valve replacement procedure , c) have thyroid dysfunction , d) 4.drink alcohol, e) have CRF, f) have history of atrial fibrilation, g) have history of mitral regurgitation or mitral stenosis and h) refused to participate.
Study participants: Patients who scheduled to undergo their first coronary artery bypass grafting in Afshar Heart Centre of Yazd aged 35-75 years.
Sample size: 180
Intervention and time: Periaortic fat pad removal during coronary artery bypass grafting.
Primary outcome: Postoperative atrial fibrillation, length of hospital stay, in-hospital morbidity and mortality.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042013071N1
Registration date:2014-11-26, 1393/09/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-26, 1393/09/05
Registrant information
Name
Neda Fotoohi Ardakani
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1820 8164
Email address
masoud.mirzaei@sydney.edu.au
Recruitment status
Recruitment complete
Funding source
Shahid Sadughi University of Medicine Siences
Expected recruitment start date
2014-09-20, 1393/06/29
Expected recruitment end date
2014-12-20, 1393/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preaortic fat pad preservation on atrial fibrillation post off-pump coronary artery bypass grafting (CABG)
Public title
Effect of preaortic fat pad preservation on arrhythmia
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Candidate for CABG and being in the 35-75 years age group. Patients were excluded if; had repeat CABG, concomitant valve replacement procedure, thyroid dysfunction, alcoholism, CRF, History of AF, History of mitral regurgitation or mitral stenosis and refused to participate.
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
masoud.mirzaei@sydney.edu.au
Secondary trial Id
3zx3
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughy University of Medical Siences
Street address
Bahonar sqr.Yazd
City
Yazd
Postal code
89491-61211
Approval date
2012-03-03, 1390/12/13
Ethics committee reference number
130344
Health conditions studied
1
Description of health condition studied
Post coronary artery bypass grafting atrial fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter
2
Description of health condition studied
impact of AFP maintenance on the hospital length of stay
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass and valve grafts
Primary outcomes
1
Description
post CABG atrial fibrillation
Timepoint
Immediately after bypass surgery until discharge from the hospital
Method of measurement
ِin Intensive care unit with evaluation of continuous monitoring print and for Hospitalized patients with electrocardiography every 6 hours or when the patient is symptomatic
2
Description
to evaluate hospital length of stay, and determine the impact of AFP retention on several safety parameters (another arrhythmia, myocardial infarction, bradycardia, mortality, and stroke)
Timepoint
24 hours after intervention
Method of measurement
Time, ECG, troponin test
Secondary outcomes
1
Description
Other cardiac arrhythmias, mortality and morbidity rates, length of hospital stay
Timepoint
Immediately after the intervention until discharge from hospital
Method of measurement
Continuous monitoring in the intensive care unit, ECG every 6 hours daily patient visits and questionnaires
Intervention groups
1
Description
Retain fat pad around the aorta during coronary artery bypass surgery in the intervention group
Category
Treatment - Surgery
2
Description
Standard coronary artery bypass grafting in the control group
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Heart Centre
Full name of responsible person
Mahdi Hadadzadeh
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadughi University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Afshar Heart Hospital
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadughi 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
Afshar Heart Centre
Full name of responsible person
Neda Fotoohi Ardakani
Position
GP
Other areas of specialty/work
Street address
Afshar Heart Centre, Jomhoori Blvd,Yazd
City
Yazd
Postal code
Phone
+98 35 1820 8164
Fax
Email
neda.fotoohi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadughi University of Medical Sciences
Full name of responsible person
Mahdy Hadadzadeh
Position
Cardiovascular Sergeon
Other areas of specialty/work
Street address
Afshar Heart Centre, Jomhoory Blvd,Yazd
City
Yazd
Postal code
Phone
+91 23960355
Fax
Email
mehad51@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Afshar Heart Centre of Yazd
Full name of responsible person
Masoud Mohammadi
Position
MSc of Epidemiology
Other areas of specialty/work
Street address
Jomhouri Blvd.
City
Yazd
Postal code
Phone
+98 35 1524 1214
Fax
Email
mmirzaei@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)