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IRCT20211226053525N1 IRCT 2022-01-22 Rasht University of Medical Sciences Determining the effectiveness of Remote Ischemic Postconditioning in the treatment of patients with ischemic stroke Determining the effectiveness of Remote Ischemic Postconditioning in the treatment of patients with ischemic stroke - Randomized Clinical trial 2022-02-04 anticipated 160 Complete https://irct.ir/trial/61004 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, restricted randomization method in the form of block randomization will be used to allocate patients into intervention and control groups. For this purpose, four blocks with a ratio of 1: 1 will be considered. Sequences are marked in sealed envelopes with the letters A (intervention group) and B (control group). We will consider the size of the blocks randomly with a size of 4 or 6 to prevent the latest allocation from being detected. In the randomization process, random allocation sequences are identified by a statistician, and student collaborator in the project will register participants and allocate them to interventions, Blinding description: In order to blind the subjects (patients) in the control group, the sphygmomanometer will be placed around patients' arm uninflated. In order to blind the researcher, allocators determine the groups without prior information using the allocation concealment method. The project will be performed based on patients groups by nurses or trained individuals. Final evaluation will be done by evaluators and physicians. In this study, restricted randomization method in the form of block randomization will be used to allocate patients into intervention and control groups. N/A Ischemic stroke. Intervention 1: Intervention group: Remote Ischemic Postconditioning (RIPC) procedure will be performed on the first day of hospitalization under the following protocol: Sphygmomanometer will be attached to the patient's healthy arm and will be remained under the pressure of 180 (or 30mmHg more than patient's systolic BP if SBP>=180) mmHg for 5 minutes (ischemic phase) , followed by 3 minutes of rest (reperfusion phase). This cycle will be performed 5 times. All patients (both intervention group and control group) will receive the routine treatment in stroke management. The time from the onset of the stroke to RIPC should be less than 24 hours, with a golden time of 6 hours. The performance comparison of the two groups will be measured by National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (MRS) criteria on days 0, discharge and 90. For biochemical measurements, the patient's serum will be sent to the laboratory and measured using routine methods. Intervention 2: Control group: RIPC procedure will be performed on the first day of hospitalization under the following protocol: Sphygmomanometer will be attached uninflated to the patient's healthy arm for 5 minutes , followed by 3 minutes of rest. This cycle will be performed 5 times. All patients (both intervention group and control group) will receive the routine treatment in stroke management. The time from the onset of the stroke to RIPC should be less than 24 hours, with a golden time of 6 hours. The performance comparison of the two groups will be measured by NIHSS and MRS criteria on days 0, discharge and 90. For biochemical measurements, the patient's serum will be sent to the laboratory and measured using routine methods. 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 I haven't decided yet - the release schedule is still unknown
public Dr. Mozafar hosseininezhad
Namjoo Street
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3332 5783 hosseininezhadm@gmail.com Rasht University of Medical Sciences scientific Dr. Mozafar hosseininezhad
Namjoo street
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3332 5783 hosseininezhadm@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) No dependence on care before the stroke and MRS score <= 2 Presence of a CT SCAN or MRI indicating the occurrence of the stroke National Institutes of Health Stroke Scale (NIHSS) score between 5 and 15 at the beginning Less than 24 hours interval between the occurrence of the stroke and the onset of RIPC Signed informed consent by patients or companions no limit no limit Both Cerebral diseases such as intracranial aneurysm, vascular malformation and dementia Previous brain surgery, hemorrhagic stroke or ischemic stroke in the last 3 months Pregnancy Severe comorbidity (incurable disease, advanced cancer with low life expectancy, renal and hepatic failure, rheumatic diseases) Peripheral vascular disease, severe liver disease, history of chronic lung disease, liver disease, kidney disease, doctor's order I67.8 Other specified cerebrovascular diseases Treatment - Other Treatment - Other Intervention group: Remote Ischemic Postconditioning (RIPC) procedure will be performed on the first day of hospitalization under the following protocol: Sphygmomanometer will be attached to the patient's healthy arm and will be remained under the pressure of 180 (or 30mmHg more than patient's systolic BP if SBP>=180) mmHg for 5 minutes (ischemic phase) , followed by 3 minutes of rest (reperfusion phase). This cycle will be performed 5 times. All patients (both intervention group and control group) will receive the routine treatment in stroke management. The time from the onset of the stroke to RIPC should be less than 24 hours, with a golden time of 6 hours. The performance comparison of the two groups will be measured by National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (MRS) criteria on days 0, discharge and 90. For biochemical measurements, the patient's serum will be sent to the laboratory and measured using routine methods. Control group: RIPC procedure will be performed on the first day of hospitalization under the following protocol: Sphygmomanometer will be attached uninflated to the patient's healthy arm for 5 minutes , followed by 3 minutes of rest. This cycle will be performed 5 times. All patients (both intervention group and control group) will receive the routine treatment in stroke management. The time from the onset of the stroke to RIPC should be less than 24 hours, with a golden time of 6 hours. The performance comparison of the two groups will be measured by NIHSS and MRS criteria on days 0, discharge and 90. For biochemical measurements, the patient's serum will be sent to the laboratory and measured using routine methods. National Institutes of Health Stroke Scale (NIHSS). Timepoint: On admission, at discharge and on day 90. Method of measurement: Calculation of score through questionnaire and based on patient examination. Modified Rankin Scale (MRS). Timepoint: On admission, at discharge and on day 90. Method of measurement: Calculation of score through based on patient examination and scale. Clinical outcome. Timepoint: at discharge. Method of measurement: Based on patients' files. Hospital stay. Timepoint: at discharge. Method of measurement: Based on patients' files. Blood sugar. Timepoint: On admission, at discharge and on day 90. Method of measurement: Based on patient test results. Blood pressure. Timepoint: On admission, at discharge and on day 90. Method of measurement: based on examination. Blood indices: Cell blood count (CBC), Prothrombin time (PT), The international normalized ratio (INR), Partial Thromboplastin Time (PTT). Timepoint: On admission, at discharge and on day 90. Method of measurement: Based on patient test results. Creatine kinase total. Timepoint: On admission, at discharge and on day 90. Method of measurement: Based on patient test results. Creatinine (Cr). Timepoint: On admission, at discharge and on day 90. Method of measurement: Based on patient test results. Liver enzymes: Aspartate aminotransferase (AST) , Alanine transaminase (ALT). Timepoint: On admission, at discharge and on day 90. Method of measurement: Based on patient test results. Rasht University of Medical Sciences Approved 2021-12-15 Research Ethic Committees of Guilan University of Medical science Guilan University of Medical science Rasht Guilan Iran (Islamic Republic of)