PRE, post-treatment of SGLT-2 Inhibitor on myocardial infarct size and remodeling index measured by cardiac maGnetic rEsonance imaging in patients with Acute Myocardial Infarction and high risk of heart failure undergoing percutaneous coronary intervention (PRESTIGE-AMI)

Samsung Medical Center0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年6月24日

适应症

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•Inclusion Criteria
•(1)Subject must be at least 18 years of age
•(2)Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving SGLT-2 inhibitor and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
•(3)Diagnosis of Type 1 myocardial infarction (MI) (STEMI or Non-ST-segment elevation MI)
•1)Detection of a rise and/or fall of cTn values with at least 1 value above the 99th percentile URL
•2)Symptoms or electrocardiographic changes suggesting myocardial ischemia
•(4)At high risk of heart failure (at least one of the two criteria below are met)
•1)Left ventricular ejection fraction < 50%
•2)Symptoms or signs of pulmonary congestion requiring treatment

•Exclusion Criteria
•(1)Target lesion is not suitable for PCI by operator’s decision
•(2)Patients requiring cardiopulmonary resuscitation due to cardiac arrest before randomization
•(3)Rescue PCI after thrombolysis or facilitated PCI
•(4)Previous MI
•(5)Previous history of heart failure
•(6)Patients who have been taking SGLT-2 inhibitor
•(7)Patients with glomerular filtration rate < 30ml/min/1.73m2 or on dialysis
•(8)Type 1 DM
•(9)Known hypersensitivity or contraindications to study medications (SGLT-2 inhibitor)
•(10)Pregnant or lactating women
•(11)Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator’s medical judgment)

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