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IRCT20190120042428N1 IRCT 2022-09-16 Tehran University of Medical Sciences Evaluation of short-term and mid-term results of using a cardiopulmonary pump in coronary artery bypass graft surgery Comparison of Short- and Mid-term Outcomes of Off-pump and On-pump Coronary Artery Bypass Grafting (CABG) surgery in Patients With 3-vessel Coronary Artery Disease: A Randomized Clinical Trial 2020-06-20 anticipated 272 Complete https://irct.ir/trial/37331 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by the method of "limited randomization" and using the method of blocks of equal size (each block of four patients). By convention, we assign two letters A and B to each type of surgery (off-pump and on-pump). In each block, we will have different permutations of A and B, but an equal number of each intervention (2 to A and 2 to B). In this way, we will have six blocks. Then the sequence of these blocks will be made randomly by the random sequence generation software "Random Allocation Software", which according to the sample size of 272, we will have 68 blocks. Then, in order to hide the random allocation, the "central randomization" method will be used. In this method, sequence information will be provided to someone outside of the study process in the research center, and researchers will be informed of the type of intervention assigned to that patient by phone call based on the order of patients entering the study. This process will continue until the last patient, Blinding description: According to the contract, one of the letters A and B is assigned to each type of surgery (Off-pump and On-pump) before the start of the study. Due to the nature of the intervention (type of surgery), which cannot be blinded for the surgeon and the main staff of the surgical team, blinding of the intervention is done for the patients, doctors, and those responsible for collecting the data of the outcome of the post-surgery study and the data analyst, and these people They will not know about the type of intervention assigned to groups A and B, and in the information available to these people, the type of intervention is indicated by the letters mentioned. 4 coronary artery disease. Intervention 1: Intervention group: patients who underwent coronary artery bypass surgery without the use of a cardiopulmonary pump device. In these patients, the anastomosis of the graft vessels on the coronary vessels will be performed on the beating heart, and the surgical area will be kept stable by standard stabilizers. Other surgical procedures will be the same as the conventional On-pump method. Intervention 2: Control group: patients who undergo surgery using a cardiopulmonary pump device. In these cases, using cardioplegic drugs and cannulating the aorta, and transferring blood pumping to the cardiopulmonary pump device, graft anastomosis will be performed on the coronary arteries in the condition of a heart without beating. Other surgical procedures will be similar to the Off-pump method. Yes - There is a plan to make this available What will be shared: All clinical information of patients without personal information after patient de-identification When: Six months after the publication of the results To whom: All biological science researchers Conditions: For inclusion in review studies or referring to result of current study in publications Where to obtain: The data will be accessible by sending an official request to mmd.forouzan@gmail.com How to obtain: Requests will be accessible to the requester by sending the data file via email after being reviewed by the Tehran Heart Center Research Council Comments:
public Seyed Khalil Forouzannia
North Kargar-Ave , Tehran-Iran
Tehran Iran (Islamic Republic of) 999999999 +98 21 8802 9600 mmd.forouzan@gmail.com Tehran University of Medical Sciences scientific Seyed Khalil Forouzannia
North Kargar-Ave , Tehran-Iran
Tehran Iran (Islamic Republic of) 99999999 +98 21 8802 9600 mmd.forouzan@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) patients with 3 vessels coronary artery disease Candidates for coronary artery bypass graft surgery 18 years no limit Both require emergency operation combined valve surgery history of cardiac surgeries patients with cardiogenic shock patients with preoperative Intra-aortic balloon pump patients with single or two vessel disease patients with contraindication to off-pump CABG history of renal failure I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Surgery Treatment - Surgery Intervention group: patients who underwent coronary artery bypass surgery without the use of a cardiopulmonary pump device. In these patients, the anastomosis of the graft vessels on the coronary vessels will be performed on the beating heart, and the surgical area will be kept stable by standard stabilizers. Other surgical procedures will be the same as the conventional On-pump method. Control group: patients who undergo surgery using a cardiopulmonary pump device. In these cases, using cardioplegic drugs and cannulating the aorta, and transferring blood pumping to the cardiopulmonary pump device, graft anastomosis will be performed on the coronary arteries in the condition of a heart without beating. Other surgical procedures will be similar to the Off-pump method. Major adverse cardiovascular events (MACE). Timepoint: 1, 3, 6, 12 months after surgery and then every 6 months until the end of the study. Method of measurement: The occurrence and type of major adverse cardiovascular events will be recorded during routine visits after surgery (at 1, 3, 6, and 12 month intervals) and at other intervals by telephone follow-up. Research Council of Tehran University of Medical Sciences Approved 2020-06-20 Ethics Committee of Tehran Heart Center North Kargar-Ave Tehran Tehran Iran (Islamic Republic of)