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

Launched by SAMSUNG MEDICAL CENTER · May 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called SGLT-2 inhibitor can help reduce the damage to the heart and improve recovery in patients who have had a heart attack and are at high risk of developing heart failure. The researchers will compare the results from patients who receive the SGLT-2 inhibitor before and after a procedure to open blocked arteries (called percutaneous coronary intervention) with those who do not receive the medication. They will look at heart scans and clinical outcomes to see how effective and safe the treatment is.

To participate in this trial, individuals must be at least 18 years old and have experienced a specific type of heart attack, along with symptoms indicating a high risk of heart failure, such as a weakened heart function or fluid buildup in the lungs. Participants will need to provide consent and can expect regular monitoring and assessments during the study. It's important to note that certain conditions, like previous heart attacks or specific kidney issues, may exclude individuals from joining the trial. If you or a loved one are interested in this study, it could provide valuable insights into new treatment options for heart health.

Gender

ALL

Eligibility 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)