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IRCT20120520009801N5 IRCT 2021-09-13 Mashhad University of Medical Sciences Evaluation the effect of Trans Sodium Crocetinate(TSC) on re perfusion Injury in Acute Myocardial Infarction Evaluation the effect of Trans Sodium Crocetinate(TSC) on re perfusion Injury in Acute Myocardial Infarction with ST elevation segment: a triple-blind, randomized, placebo-controlled trial 2021-09-23 anticipated 100 Complete https://irct.ir/trial/58090 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Alternate block randomization using www.randomization.com. Each block has 4 components and the mentioned site selects twenty-five blocks out of quadruple blocks randomly, so finally 100 patients are included in the study. The allocation concealment method is by use of opaque sealed envelopes with random sequences obtained from the random allocation step, Blinding description: The vials will be marked with the letters A and B, and since the placebo will also be made by the Industrial Department of the School of Pharmacy, we will not have a problem with masquerade. It will be the same with pills. Physician, injecting drug nurse, clinical pharmacy resident, patients, and results analyzer will remain unaware of the type of formulation until completed. 3 STEMI. Intervention 1: Intervention group: Patients under PCI who receive trans sodium crocetinate"""(TSC) at a dose of 0.5 mg / kg body weight by injection within 2 minutes, 5 minutes before PCI, in addition to standard treatments for acute myocardial infarction, then take crocetin oral tablets on days 0 to 3 At a dose of 7.5 mg, they take 3 tablets a day. Intervention 2: Control group: Patients under PCI receive normal saline at a dose of .05 mg/v in addition to standard treatments for acute myocardial infarction within 2 minutes, 5 minutes before PCI, and then 3 placebo tablets on days 0 to 3. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: starting 6 months after publication To whom: only available for people working in academic institutions Conditions: only available for people working in academic institutions and there is not another condition Where to obtain: mohamadpoorah@mums.ac.ir How to obtain: mohamadpoorah@mums.ac.ir Comments:
public Amir Hooshang Mohammadpour
School of Pharmacy, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 6519472972 +98 51 1882 3255 mohamadpoorah@mums.ac.ir Mashhad University of Medical Sciences scientific Amir Hooshang Mohammadpour
School of Pharmacy, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 6519472972 +98 51 1882 3255 mohamadpoorah@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients should be between 18 and 76 years old Patients with myocardial infarction with an ascending ST segment Meet the entry requirements under the AHA2019 guideline Candidates for PPCI Zero TIMI score at admission 18 years 76 years Both Be pregnant or breastfeeding History of allergy to formulations used in the study.• The patient enters another similar plan and receives other drugs that affect treatment response in the past month The person has cardiogenic shock and is forced to use pressure therapy The patient has IABP History of acute myocardial infarction GFR less than 60 ml / min• Patients with cardiac arrest Patient with VF Patient with hepatic impairment AST / ALT> 5ULN Patient with a history of chronic inflammatory disease Patient with LMCA involvement Patient with a history of myocardial infarction or ACS within 4 hours before the current episode I21.3 ST elevation (STEMI) myocardial infarction of unspecified site Prevention Placebo Intervention group: Patients under PCI who receive trans sodium crocetinate"""(TSC) at a dose of 0.5 mg / kg body weight by injection within 2 minutes, 5 minutes before PCI, in addition to standard treatments for acute myocardial infarction, then take crocetin oral tablets on days 0 to 3 At a dose of 7.5 mg, they take 3 tablets a day Control group: Patients under PCI receive normal saline at a dose of .05 mg/v in addition to standard treatments for acute myocardial infarction within 2 minutes, 5 minutes before PCI, and then 3 placebo tablets on days 0 to 3. Quantitative amounts of Troponin I Tn I enzyme and drawing the shape of the Tn I time concentration curve. Timepoint: At zero time, 6, 12 and 24 hours after PPCI. Method of measurement: High-Sensitivity Troponin Test-Laboratory. Evaluation of the patient's electrocardiogram and recording of ventricular and supraventricular arrhythmias, number of PVCs, PR / QT / QRS intervals, and evaluation of the cumulative amount of ST segment (STR Percentage). Timepoint: Daily until discharge. Method of measurement: Through ECG examination. Ejection fraction and evaluation of systolic and diastolic status of all 4 chambers of the heart and LV ENLARGMENT. Timepoint: Daily until discharge. Method of measurement: Echocardiography. Evaluation of biochemical parameters INR, BUN, Scr Na, K, Ca, Mg, ALT, AST. Timepoint: Daily until discharge. Method of measurement: Laboratory. Evaluation of the balance between oxidants - antioxidants. Timepoint: Two samples at time zero and patient discharge time. Method of measurement: Laboratory. Mashhad University of Medical Sciences Approved 2021-08-11 Mashhad University of Medical Sciences Ethic committee of Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah stree Mashhad Razavi Khorasan Iran (Islamic Republic of)