Peri-procedure SGLT-2 inhibitor to reduce heart attack damage and heart remodeling
Peri-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
This trial will test whether taking an SGLT‑2 diabetes medicine around the time of PCI can shrink the heart attack scar and limit heart remodeling in adults with acute myocardial infarction who are at high risk for heart failure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04899479 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with type 1 acute myocardial infarction (STEMI or NSTEMI) undergoing PCI who are at high risk for heart failure (for example LVEF <50% or signs of pulmonary congestion) and can provide informed consent.
Not a fit: Patients who cannot undergo PCI, who require immediate cardiopulmonary resuscitation, or who have contraindications to SGLT‑2 inhibitors (for example severe kidney impairment or other contraindications) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, peri-procedural SGLT‑2 inhibitor use could reduce infarct size and adverse remodeling, potentially lowering heart failure and death after acute MI.
How similar studies have performed: SGLT‑2 inhibitors have shown clear benefits in chronic heart failure and long-term cardiovascular outcomes, but evidence specifically testing peri-PCI use to reduce acute infarct size is limited and largely exploratory.
Eligibility criteria
Show full inclusion / exclusion 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) (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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.