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IRCT20200510047380N2 IRCT 2022-01-29 Rasht University of Medical Sciences The effect of ischemic preconditioning in patients with acute Myocardial infraction A study on effects of ischemic preconditioning on the occurrence rate of major cardiovascular complications in patients suffering from acute myocardial infraction with ST segment elevation 2021-12-22 anticipated 160 Complete https://irct.ir/trial/60309 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the estimated sample size, 80 patients in the intervention group and 80 patients in the control group based on consecutive sampling and having inclusion criteria based on four random blocks whose sequence by Sealed Envelope software Ltd.2021.Created a block Randomisation list {Online} Available from: https://www.sealedenvelope.com/simple -randomiser / v1 / lists {Accessed 13 Sep 2021} The list is kept inside a sealed letter at the Healthy Heart Research Center. After permission to conduct the study, patients are assigned to the intervention and control groups on a daily basis. It should be noted that this sequence list consists of 40 quadruple random blocks. This study is a single-blind clinical trial study. The method of blinding in the study will be that the intervention of patients by one of the assistants and the evaluation of complications and measurement of left ventricular ejection fraction by another assistant. Patients have no information about the type of intervention, Blinding description: This study is a single-blind clinical trial. the independent variable in this study is the intervention group against control group, the outcomes of this study(heart failure, recurring myocardial infraction, stroke and death) are the primary end points , and ejection fraction(EF) is the secondary end point. N/A ST segment elevation acute myocardial infraction. Intervention 1: Patients with acute myocardial infarction with ST-segment elevation who are candidates for Primary PCI and undergo RIC. The cuff is placed on one of the upper limbs and inflated to 30 mm/hg higher than systolic pressure for a period of 5 minutes. The process is repeated 3 times with a 5-minute interval. Intervention 2: Control group: Patients with acute myocardial infarction with ST-segment elevation who were candidates for Primary PCI. The cuff is placed on one of the upper limbs and inflated to 30 mm/hg higher than systolic pressure for a period of 5 minutes. The process is repeated 3 times with a 5-minute interval. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: Access period 6 months after printing the results To whom: Researchers working in academic and scientific institutions Conditions: In order to conduct further research at the written request of the Scientific Institute. Where to obtain: applicants for receiving documents and data can refer to the Healthy Heart Research Center located in Heshmat Hospital. They can also call 01333664282. How to obtain: The applicant can refer to the Healthy Heart Research Center after receiving Confirmation from the project manager, the documents and data will be available to him within a week. Comments:
public Seyyed Aboozar Fakhr Mousavi
Dr Heshmat Hospital, Mosalla square
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3366 3070 aboozar-fm@yahoo.com Rasht University of Medical Sciences scientific Seyyed Aboozar Fakhr Mousavi
Dr Heshmat Hospital, Mosalla square
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3366 3070 aboozar-fm@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients over 18 coming into the emergency room because of chest pain that has started less tan 12 hours before ECG shows ST elevation equaling or higher than 0/1 mill volt in two parallel leads(ST elevation equals or is higher than 0/2 mill volt in v1 to v3 leads) 18 years no limit Both Patients in cardiogenic shock Patients who die before or immediately after percutaneous coronary intervention(PCI) Patients with a history of myocardial infarction or coronary artery bypass graft 12 hours or more have elapsed since the onset of maximal chest pain I24.9 Acute ischemic heart disease, unspecified Rehabilitation Treatment - Devices Patients with acute myocardial infarction with ST-segment elevation who are candidates for Primary PCI and undergo RIC. The cuff is placed on one of the upper limbs and inflated to 30 mm/hg higher than systolic pressure for a period of 5 minutes. The process is repeated 3 times with a 5-minute interval. Control group: Patients with acute myocardial infarction with ST-segment elevation who were candidates for Primary PCI. The cuff is placed on one of the upper limbs and inflated to 30 mm/hg higher than systolic pressure for a period of 5 minutes. The process is repeated 3 times with a 5-minute interval. Patients with acute ST-segment elevation myocardial infarction. Timepoint: Before the intervention and 3 months later and 6 months after acute myocardial infarction. Method of measurement: Based on electrocardiogram tape. Heart failure, recurrent myocardial infarction, stroke and death, left ventricular ejection fraction. Timepoint: Before the intervention, 3 months later and 6 months later. Method of measurement: Through a researcher-made questionnaire and echocardiography device. Rasht University of Medical Sciences Approved 2021-09-29 Research Ethics Committees of Guilan university of medical sciences Dr Heshmat Hospital, mosalla Square, Rasht, Guilan Rasht Guilan Iran (Islamic Republic of)