Status:
RECRUITING
Peri-treatment of SGLT-2 Inhibitor on Myocardial Infarct Size and Remodeling Index in Patients With Acute Myocardial Infarction and High Risk of Heart Failure Undergoing Percutaneous Coronary Intervention
Lead Sponsor:
Samsung Medical Center
Conditions:
Acute Myocardial Infarction
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
We aimed to identify whether SGLT-2 inhibitor administration before and after coronary intervention is effective in reducing the size of infarction and myocardial remodeling in patients with acute myo...
Detailed Description
After the introduction of percutaneous coronary intervention (PCI) as a method to normalize blood flow in the treatment of coronary artery disease, not only the technical aspects of coronary intervent...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04899479
Start Date
July 5 2021
End Date
December 30 2025
Last Update
June 26 2025
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea