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IRCT20230701058631N1 IRCT 2023-07-21 Esfahan University of Medical Sciences Investigating the use of two zinc and selenium supplements on the prevalence of atrial fibrillation after open heart surgery 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 2023-07-02 anticipated 72 Complete https://irct.ir/trial/71307 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. N/A Chronic ischemic heart disease. Intervention 1: 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). Intervention 2: Control group: They receive placebo tablets daily, starting one week before the operation (at the time of visiting the clinic). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Data of participants are confidentia
public Elham Kiani
Faculty of Medicine, Isfahan University of Medical Sciences, Hazar Jarib St., Azadi Square, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3792 3071 elhamkiani350@yahoo.com Esfahan University of Medical Sciences scientific Mehran Shah Zamani
Faculty of Medicine, Isfahan University of Medical Sciences, Hazar Jarib St., Azadi Square, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3071 m.shahzamani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 40 years 70 years Both History of atrial fibrillation rhythm before surgery Combined coronary artery and heart valve surgery Selenium and zinc deficiency Anemia I25.1 Atherosclerotic heart disease of native coronary artery Prevention Placebo 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). Atrial fibrillation. Timepoint: After surgery. Method of measurement: Electrocardiogram (ECG). Ejection fraction. Timepoint: After surgery. Method of measurement: Echocardiography. Occurrence of bleeding. Timepoint: After surgery. Method of measurement: Nursing chart on file. Esfahan University of Medical Sciences Approved 2023-07-01 Ethics committee of medical school, Isfahan University of Medical Sciences Faculty of Medicine, Isfahan University of Medical Sciences, Hazar Jarib St., Azadi Square, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)