PRE, post-treatment of SGLT-2 Inhibitor on myocardial infarct size and remodeling index in patients with AMI and high risk of heart failure undergoing PCI (PRESTIGE-AMI)

Not Applicable

Conditions: Diseases of the circulatory system

Registration Number: KCT0006219

Lead Sponsor: Samsung Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

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

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)

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infarct sized measured using cardiac magnetic resonance imaging;Difference of left ventricular end-systolic volume measured by CMR between baseline and 6-month (?left ventricular end-systolic volume)

Secondary Outcome Measures