Empagliflozin on Cardiac-renal Injury in Patients With STEAMI Patients After Primary PCI

Study Overview
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Brief Summary
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This study is a single-center, prospective controlled trial addressing effectiveness of empagliflozin on cardiac-renal injury in patients with STEMI. Patients were randomized using a computer-generated sequence to either placebo or empagliflozin at a 1:1 ratio. Investigators, participants, and other study personnel were blinded to the assigned treatment for the duration of the study. The primary objective of this study is to investigate the effects of empagliflozin on myocardial infarct size measured using cardiac magnetic resonance (CMR) methods at 3 months. Key secondary endpoint: incidence of CIAKI within 48h after PCI. Inclusion Criteria:Patients with STEMI who were admitted to the Chinese PLA General Hospital were recruited between Ocotor 2018 and January 2019. STEMI was defined as typical chest pain lasting >30 minutes within the previous 12 hours, a clear ST-segment elevation of >0.1 mV in two or more contiguous electrocardiographic leads, and elevated blood levels of troponin T.Exclusion Criteria:Cardiogenic shock ,Hypoglycaemia ,Diabetic ketoacidosis,Genital and urinary infections,History of myocardial infarction,Stent thrombosis,Previous coronary artery bypass surgery,Type 1 Diabetes,Severe hepatic insufficiency,Advanced cancer patients,eGFR<30 ml/min. All patients were informed of the potential risks (genital mycotic infections, urinary tract infections, diabetic ketoacidosis) associated with empagliflozin and then required to submit written informed consent before being included in the study. Patients were randomized using a computer-generated sequence to either placebo or empagliflozin at a 1:1 ratio. Patients in the empagliflozin group were treated with empagliflozin whereas patients in the control group were given placebo. The treatment started 30 minutes before PCI with a dose of 10 mg empagliflozin or placebo administered in the ambulance. After admission, patients were treated with 10 mg empagliflozin once daily for 3 mouths.

Official Title
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Effectiveness of Empagliflozin on Cardiac-renal Injury in Patients With Acute ST-segment-elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention.

Conditions
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Reperfusion Injury, Myocardial

Intervention / Treatment
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* Drug: Empagliflozin
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with STEMI who were admitted to the Chinese PLA General Hospital were recruited between June 2018 and September 2018. Exclusion Criteria: Cardiogenic shock Hypoglycaemia Diabetic ketoacidosis Genital and urinary infections History of myocardial infarction Stent thrombosis Previous coronary artery bypass surgery Type 1 Diabetes Severe hepatic insufficiency Advanced cancer patients eGFR<30 ml/min

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment group<br>Patients will be randomized into two groups after enrolled. In Empagliflozin Group, the treatment started 30 minutes before PCI with a dose of 10 mg empagliflozin .After admission, patients were treated with 10 mg empagliflozin once daily for 3 mouths. The procedure will double blind to patients and investigators. | Drug: Empagliflozin<br>* After randomization,the treatment started 30 minutes before PCI with a dose of 10 mg empagliflozin . After admission, patients were treated with 10 mg empagliflozin once daily for 3 mouths.<br>|
| Placebo Comparator: Placebo group<br>Patients will be randomized into two groups after enrolled. In Placebo Group, the treatment started 30 minutes before PCI with a dose of 10 mg Placebo .After admission, patients were treated with 10 mg Placebo once daily for 3 mouths. The procedure will double blind to patients and investigators. | Other: placebo<br>* After randomization,the treatment started 30 minutes before PCI with a dose of 10 mg placebo . After admission, patients were treated with 10 mg placebo once daily for 3 mouths.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| final infarct size | the final infarct size measured by Cardiac magnetic resonance | 3 months after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contrast induced acute kidney injury (CIAKI) | incidence of CIAKI within 48 hours after PCI | within 48 hours after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Empagliflozin, Percutaneous coronary intervention, Reperfusion Injury, Microvascular protection, CI-AKI, No-Reflow Phenomenon