Investigating the use of two zinc and selenium supplements on the prevalence of atrial fibrillation after open heart surgery in patients with coronary artery disease
Determining the use of zinc and selenium supplements on the prevalence of atrial fibrillation after open heart surgery in patients with coronary artery disease in Shahid Chamran Hospital, Isfahan.
Design
A community-based, pragmatic, control group clinical trial was randomized with parallel groups.
Settings and conduct
Intervention group: they will receive daily zinc plus tablets containing 200 micrograms of selenium, 15 mg of zinc, starting one week before the operation (at the time of visiting the clinic). Control group: they will receive a placebo. The place of study will be Shahid Chamran Hospital of Isfahan. Patients of two groups after surgery in terms of clinical criteria including: atrial fibrillation through ECG, Ejection fraction (EF) before and after surgery through echocardiography, occurrence of bleeding through nursing chart in the file are checked and compared
Participants/Inclusion and exclusion criteria
Inclusion criteria are: The patient is a candidate for coronary artery bypass surgery (CABG). Cardiac ejection fraction is above 40%. Age between 40 and 70 years. Patient willingness to participate in the study.
No entry conditions: History of atrial fibrillation rhythm before surgery, Combined coronary artery and heart valve surgery, Selenium and zinc deficiency, Anemia.
Intervention groups
Intervention group: They receive daily zinc plus tablets containing 200 micrograms of selenium and 15 mg of zinc, starting one week before the operation (at the time of visiting the clinic).
Control group: They receive placebo tablets daily, starting one week before the operation (at the time of visiting the clinic).
Main outcome variables
Atrial fibrillation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230701058631N1
Registration date:2023-07-21, 1402/04/30
Registration timing:registered_while_recruiting
Last update:2023-07-21, 1402/04/30
Update count:0
Registration date
2023-07-21, 1402/04/30
Registrant information
Name
Elham Kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 1077
Email address
elhamkiani350@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-02, 1402/04/11
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the use of two zinc and selenium supplements on the prevalence of atrial fibrillation after open heart surgery in patients with coronary artery disease
Public title
Investigating the use of two zinc and selenium supplements on the prevalence of atrial fibrillation after open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is a candidate for coronary artery bypass surgery (CABG).
Cardiac ejection fraction is above 40%
Age between 40 and 70 years
Patient willingness to participate in the study
Exclusion criteria:
History of atrial fibrillation rhythm before surgery
Combined coronary artery and heart valve surgery
Selenium and zinc deficiency
Anemia
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients between two groups is done using random assignment software (RA Software).The total number of sample size (72 people) and the number of groups (two groups) are entered into the software. The output of the software includes a list that randomly distributes the numbers 1 to 72 in two groups. Patients are entered into one of the two groups according to the time of visiting the hospital and according to the mentioned list, so that the sample size reaches the required number in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention group will receive tablets with zinc and selenium compounds and the control group will receive placebo tablets. In this study, blinding is done for the patient and the evaluator and clinical caregiver.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of medical school, Isfahan University of Medical Sciences
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hazar Jarib St., Azadi Square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
IR.MUI.MED.REC.1402.135
Health conditions studied
1
Description of health condition studied
Chronic ischemic heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Atrial fibrillation
Timepoint
After surgery
Method of measurement
Electrocardiogram (ECG)
Secondary outcomes
1
Description
Ejection fraction
Timepoint
After surgery
Method of measurement
Echocardiography
2
Description
Occurrence of bleeding
Timepoint
After surgery
Method of measurement
Nursing chart on file
Intervention groups
1
Description
Intervention group: They receive daily zinc plus tablets containing 200 micrograms of selenium and 15 mg of zinc, starting one week before the operation (at the time of visiting the clinic).
Category
Prevention
2
Description
Control group: They receive placebo tablets daily, starting one week before the operation (at the time of visiting the clinic).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital, Isfahan
Full name of responsible person
Mehran Shah Zamani
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hazar Jarib St., Azadi Square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3792 3071
Fax
Email
m.shahzamani@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Roya Kelishadi
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hazar Jarib St., Azadi Square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7500
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Elham Kiani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hazar Jarib St., Azadi Square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3792 3071
Email
elhamkiani350@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehran Shah Zamani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hazar Jarib St., Azadi Square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
m.shahzamani@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Kiani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hazar Jarib St., Azadi Square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3792 3071
Email
elhamkiani350@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available