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IRCT20200727048226N1 IRCT 2020-08-06 Tehran University of Medical Sciences Efficacy of Empagliflozin on cardiac function in non- diabetic patients after primary percutaneous angioplasty on left anterior descending coronary artery Efficacy of Empagliflozin on cardiac function in non- diabetic patients after primary percutaneous angioplasty on left anterior descending coronary artery 2020-08-22 anticipated 88 Complete https://irct.ir/trial/49991 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: this trial is a randomized double blind clinical trial with permuted block type of randomization. stratified randomization is done with statistical software.patients enter into blocks including four . and recieving placebo or empagliflozin randomizingly.first physician is blind about type of medication and second physician know the type of medication to find the probable side effect, Blinding description: patient and the first researcher are blind to give medication and data gathering. second resercher who monitors data gathering and giving medicine is not blind. in this trial, in first 48 hours of acute MI 10 mg Empagliflozin or placebo give to patient for 3 months. in the first 48 hours , all of the followings are reviewed: 1-demographic data sheet, risk factors, history of cardiovascular diseases. 2- report of angiography is reviewed from PACS. 3- contraindication of recieving of medicine is reviewed. in 48 first 48 hours and after three months, ehocardiography is done by an Echocardiologist and blood samples for FBS, CBC, BUN, Cr, BNP, HbA1C and lipid profile is given. 2 acute myocardial infarction. Intervention group: each patient recieves one 10 mg tablet of empagliflozin from abidi institute or placebo. Yes - There is a plan to make this available What will be shared: some of the information are shared When: from 6 months afer published To whom: for all researchers and scientists Conditions: analysis in data is allowed Where to obtain: hosseinisa@gmail.com How to obtain: in a week of request in email, recivivig the answer Comments:
public sara hosseini
north karegar
tehran Iran (Islamic Republic of) 111111111 00921865829828 hosseinisa1990@gmail.com Tehran University of Medical Sciences scientific sara hosseini
north karegar
tehran Iran (Islamic Republic of) 1111111111 +98 21 6582 9828 hosseinisa1990@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) non-diabetic patients with PPCI on LAD that are SVD: non-diabetic patients definition: 1-HbA1C<6.5 2-history of non-diabetes 3-twice FBS<100 if two of three of these exist patient is eligible for entery of trial 18 years no limit Both 1-History of serious hypersensitivity to empagliflozin or any component of the formulation; -Severe renal impairment (eGFR <30 mL/minute/1.73 m2), end-stage renal disease (ESRD), or dialysis 2-patients that have more than one vessel disease or have SVD with non-culprit lesion >70% or with SVD of LCX or RCA 3-patients 4- diabetic patients 121-09 Treatment - Drugs Intervention group: each patient recieves one 10 mg tablet of empagliflozin from abidi institute or placebo Efficacy of empagliflozin on cardiac function in non- diabetic patients admitted in Tehran Heart Center after primary PCI on LAD. Timepoint: echocardiography and blood sampling will be done 48 hours and after three months of reciveing medicine. Method of measurement: three dimentional echocardiography. Tehran University of Medical Sciences Approved 2020-07-30 Ethics of Tehran university of medical science north karegar, tehran heart center tehran Tehran Iran (Islamic Republic of)