]>
IRCT20210920052524N1 IRCT 2021-09-22 Rasht University of Medical Sciences Study of safety and efficacy of transplantation of platelet extracted mitochondria in heart ischemic stroke, Clinical trial phase 1 and 2 Study of safety and efficacy of transplantation of platelet extracted mitochondria in heart ischemic stroke, Clinical trial phase 1 and 2 2021-10-23 anticipated 34 Complete https://irct.ir/trial/58820 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to assign patients into intervention and control groups, the restricted randomization using block randomization will be used in this study. In order to conceal the last allocated blocks under study, the size of blocks will be consider 4 or 6. To create random numbers, various packages available in R software will be used. Of noted, before the allocation of patients/individuals in the study groups, the allocated group would not be clarified. In order to conceal and confounding factors, allocation concealment will be used. This method will be used for randomization participants in the study. In this study using sealed envelopes in which created randomized sequensces will be recorded on cards, and the cards will be put inside the envelopes respectively. the allocation would be 1:1 ratio, Blinding description: In this study, the participants (patients) would be blinded by sealed envelopes. It should be noted that each created randomized sequences will be recorded on a card, and the cards will be put inside the envelopes respectively. In order to blind researcher, similar syringes, the same color injection solutions for the control and intervention groups will be used. The analyzer will also be blinded according to coding of envelope and syringes . 1-2 Heart Ischemia. Intervention 1: Intervention group: In the intervention group, platelets derived mitochondrial is transplanted. After preparing the patient, the extracted mitochondria are injected into the coronary artery using a catheter. This group receives all routine interventions similar to control group. Intervention 2: Control group: This group receives routine medications and treatments such as angioplasty. Yes - There is a plan to make this available What will be shared: Age, sex, cancer incidence, bleeding and side effects When: After publishing the results in the article To whom: Universities Conditions: Only for study Where to obtain: Dr.Mehryar Habibi Roudkenar Email: roudkenar@gums.ac.ir How to obtain: The request must be written to the Vice Chancellor for Research of Guilan University of Medical Sciences. The request is sent to the principal investigator and the researcher will send the documents to the deputy. The applicant can receive the documents from the deputy. Comments:
public Mehryar Habibi Roudkenar
3th floor, Burn and Regenerative Research Medicine Center, Velayat Hospital, Namjo street, Rasht, Guilan
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Roudkenar@gums.ac.ir Rasht University of Medical Sciences scientific Mehryar Habibi Roudkenar
3th floor, Burn and Regenerative Research Medicine Center, Velayat Hospital, Namjo street, Rasht, Guilan
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Roudkenar@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Participants, their close relatives or lawyers are able to sign a consent form; Patients with recent myocardial ischemia within 24 hours Candidate for interventional treatment. Ejection fraction less than or equal to 41% (EF ≤ 41%). The age range is between 45-70 years Both Genders 45 years 70 years Both Patients with mitochondrial disorders. Patients with diabetes Patients with renal failure. Pregnant women Patients with cancer are not included in the study. I24.9 Acute ischemic heart disease, unspecified Treatment - Other Treatment - Drugs Intervention group: In the intervention group, platelets derived mitochondrial is transplanted. After preparing the patient, the extracted mitochondria are injected into the coronary artery using a catheter. This group receives all routine interventions similar to control group. Control group: This group receives routine medications and treatments such as angioplasty. Cardiac arrhythmia. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Based on diagnostic tests and physician reports. Non-fatal heart ischemia. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Based on diagnostic tests and physician reports. Fever and shivering. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Thermometer. Vital signs change. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Barometer and diagnostic tests. Death. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Patients records. Cardiac enzymes Creatine kinase MB, cardiac troponin I. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: laboratory kits. Re-hospitalization. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: According to patient file. Left Ventricular Ejection Fraction (LVEF). Timepoint: 3 and 6 months after mitochondrial transplantation. Method of measurement: Echocardiography. Left Ventricular End Diastolic Volume Index (LVEDVI). Timepoint: 3 and 6 months after mitochondrial transplantation. Method of measurement: Echocardiography. Left Ventricular End Systolic Volume Index (LVESVI). Timepoint: 3 and 6 months after mitochondrial transplantation. Method of measurement: Echocardiography. Patient physical activity. Timepoint: 3 and 6 months after mitochondrial transplantation. Method of measurement: The Tests such as six-minute walk test and a treadmill test. Rasht University of Medical Sciences Approved 2021-08-31 Ethics Committee of Guilan University of Medical Sciences 3th floor, Burn and Regenerative Research Medicine Center, Velayat Hospital, Namjo street, Rasht, Guilan Rasht Guilan Iran (Islamic Republic of)