Evaluation of the reduction in the incidence of atrial fibrillation following the administration of vitamin C in patients with open heart surgery
Design
Randomized controlled trial, Triple blinded, Phase 2 on 140 patients, Randomisation was done with used a random number table
Settings and conduct
By multi-stage random sampling, among patients undergoing CABG at Buali Sina Hospital in Qazvin
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients candidates for coronary artery bypass grafting and exclusion criteria: history of previous atrial fibrillation; having a permanent pacemaker; any definite or possible evidence of any ventricular or supraventricular arrhythmia; severe left ventricular enlargement; severe valvular heart disease; myocardial infarction and ejection fraction less than or equal to 30%.
Intervention groups
Group "A" is the intervention group for which vitamin C at a daily dose of 1 gram was started 24 hours before surgery and continued until 48 hours after surgery. While patients in group "B" or the same control group were prescribed placebo. It should be noted that in both groups, due to the proven effect of atorvastatin in reducing the incidence of atrial fibrillation in order not to deprive patients at a dose of 40 mg daily was prescribed.
Main outcome variables
Incidence of AF in patients after CABG
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201102049232N2
Registration date:2021-01-10, 1399/10/21
Registration timing:retrospective
Last update:2021-01-10, 1399/10/21
Update count:0
Registration date
2021-01-10, 1399/10/21
Registrant information
Name
Ali Pazoki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 6034
Email address
a.pazoki@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-28, 1396/02/08
Expected recruitment end date
2018-07-31, 1397/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral Vitamin C on rate of Atrial Fibrillation in Post-CABG patients referred to BuAli Sina hospital in Qazvin during 2017-2018
Public title
Effect of oral Vitamin C on rate of Atrial Fibrillation in Post-CABG patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients that are candidate for coronary artery bypass graft surgery
Exclusion criteria:
History of previous atrial fibrillation
Having a permanent pacemaker
Any conclusive or probable evidence of any ventricular or supraventricular arrhythmias
Severe valvular disease
heart attack
EF≤30%
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is three-blind and each patient receives a code and both patients who received vitamin C and did not receive vitamin C. are performed by one of the nurses. The main collaborators of the project and the patients and the person who finally analyzes the results are all unaware of which patient is in which group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin university of Medical Sciences
Street address
Qazvin university of medical sience, Shahid Bahonar blvd.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2017-03-21, 1396/01/01
Ethics committee reference number
IR.QUMS.REC.1397.406
Health conditions studied
1
Description of health condition studied
Atrial Fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter
Primary outcomes
1
Description
Incidence of atrial fibrillation after coronary artery surgery
Timepoint
Along with the intervention
Method of measurement
Number of cases and counting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: There are 70 patients in the complementary or intervention group. These patients will receive 1 gram of vitamin C orally the day before (24 hours before) surgery and will continue for up to 48 hours after surgery.
Category
Prevention
2
Description
Control group:There are 70 patients in the control group. These patients will receive the placebo orally the day before (24 hours before) surgery and will continue for up to 48 hours after the operation.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
BuAli Sina Hospital
Full name of responsible person
Ali Pazoki
Street address
BuAli Sina Hospital, Booali Sina Street
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
dralipazoki@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Emamjomeh
Street address
BuAli Sina Hospital, Booali Sina Street
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 7006
Email
memamjomeh@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Ali Pazoki
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
BuAli Sina Hospital, Booali Sina Street
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
dralipazoki@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ali Pazoki
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
BuAli Sina Hospital, Booali Sina Street
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
dralipazoki@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ali Pazoki
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
BuAli Sina Hospital, Booali Sina Street
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
dralipazoki@gmail.com
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
Information about main outcome and results
When the data will become available and for how long
Late 1400
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For scientific exploitation
From where data/document is obtainable
Ali Pazoki
What processes are involved for a request to access data/document
Send an email explaining the reason for the request