Peri-procedure SGLT-2 inhibitor to reduce heart attack damage and heart remodeling

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with acute myocardial infarction (STEMI or NSTEMI) at high risk for heart failure who undergo percutaneous coronary intervention will be given an SGLT‑2 inhibitor around the time of the procedure or receive standard care. Cardiac magnetic resonance imaging (CMR) will be used to measure infarct size and markers of myocardial remodeling, and clinical outcomes and safety events will be recorded. The trial compares CMR parameters and clinical endpoints between the SGLT‑2 group and a control group to determine peri-procedural effects. The protocol is conducted at Samsung Medical Center and focuses on early intervention to limit reperfusion injury and subsequent remodeling.

Why it matters

Who can join: the full rules

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) (ST-segment elevation MI \[STEMI\] or Non-ST-segment elevation MI \[NSTEMI\]) i) Detection of a rise and/or fall of cardiac troponin values with at least 1 value above the 99th percentile upper reference limit ii) Symptoms or electrocardiographic changes suggesting myocardial ischemia 4) High risk of heart failure (at least one of the two criteria below are met) i) Left ventricular ejection fraction \< 50% ii) 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 diabetes mellitus (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)

Where it's running

• Samsung Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Young Bin Song, MD, PhD
• Email: youngbin.song@gmail.com
• Phone: 82-2-3410-1246

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.