Henagliflozin Reducing Infarct Size After Priamry PCI in Patients With ST Segment Elevation Myocardial Infarction

Phase 4

Recruiting

• Conditions: Heart Failure; Myocardial Infarction
• Interventions: Drug: Henagliflozin

• Registration Number: NCT06187727
• Lead Sponsor: Qian geng

Brief Summary

This Randomized controlled intervention study recruited patients diagnosed with ST-segment elevation myocardial infarction (STEMI). A total of 240 patients were enrolled in either Henagliflozin group or control group. Patients in Henggliflozin group will be given by oral administration of Henggliflozin for 6 months post acute myocardial infarction. Prior to procedure, dynamic changes in myocardial enzymes were monitored. Major cardiovascular events, including non-fatal myocardial infarction, all-cause death, revascularization due to angina, and hospitalization for acute heart failure. This study aims to assess the impact of Henggelizin intervention on the reduction of myocardial infarction size (evaluated by cardiac enzyme) and improvement of left ventricular remodeling in patients with ST-segment elevation myocardial infarction.

Detailed Description

This Randomized controlled intervention study recruited patients diagnosed with ST-segment elevation myocardial infarction (STEMI) who were scheduled to undergo emergency percutaneous coronary intervention (PCI) . A total of 240 patients were selected for both the Henagliflozin group and control group. In the emergency room, clinical data would be collected, along with peripheral venous blood samples for laboratory examination. This examination should include blood routine analysis, myocardial enzyme, blood glucose levels, liver and kidney function, and brain natriuretic peptide precursor (NT proBNP) measurement. After primary PCI, Henggliflozin was administered, followed by daily oral administration of one tablet until 6 months post-acute myocardial infarction. Prior to procedure, dynamic changes in myocardial enzymes and electrocardiogram were monitored, with subsequent monitoring at 6 hours, 24 hours, and 48 hours after myocardial infarction. Perioperative complications were documented, followed by cardiac ultrasound assessments of myocardial wall motion and cardiac structure at seven days post primary PCI and six months post procedure. Major cardiovascular events, including non-fatal myocardial infarction, all-cause death, revascularization due to angina, and hospitalization for acute heart failure, were observed through follow-up at 1 month, 2 months, 3 months, and 6 months after PCI. This study aims to assess the impact of postoperative Henggelizin intervention on the reduction of myocardial infarction size and improvement of left ventricular remodeling in patients with ST-segment elevation myocardial infarction (STEMI).

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2023-11
• Study First Submitted: 2023-12-17
• Study First Submitted QC: 2023-12-17
• Last Update Submitted: 2023-12-17
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. STEMI patients with clear diagnosis: ischemic chest pain lasting for more than 30 minutes and adjacent to two or more leads of ST Segment elevation (limb lead ≥ 0.1mV, chest lead ≥ 0.2mV) with or without elevated myocardial enzyme levels;
2. Chest pain lasting less than 12 hours;
3. Age range from 18 to 80 years old;
4. Plans to undergo primary PCI ;
5. Informed consent form

Exclusion Criteria

1. Mechanical complications;
2. Cardiogenic shock;
3. Experienced myocardial infarction within 6 months;
4. Aortic dissection;
5. Suffering from malignant tumors, severe liver and kidney failure, respiratory failure, or other short-term progressive diseases that researchers believe cannot be included
6. Urinary system infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
henagliflozein group	Henagliflozin	Patients in henagliflozein group was given henagliflozein once a day for 6 months after myocardial infarction.

Primary Outcome Measures

Name	Time	Method
Area under the curve of myocardial enzymes (CK-MB)	3 days after the primary PCI	Postoperative dynamic monitoring of myocardial enzyme （CK-MB）changes post infarction

Secondary Outcome Measures

Name	Time	Method
Infarct size	7 days after the primary PCI	Infarct size measured by cardiac magnetic resonance imaging
contrast induced by nephropathy	5 days after the primary PCI	absolute increase in serum creatinine (SCr) 48-72 hours after primary PCI \> 0.5 mg/dl or a relative increase \> 25% compared with baseline SCr.
Left ventricular remodeling	6 months after primary PCI	Left ventricular remodeling evaluated by echocardiography，left ventricular end diastolic volume increase more than 20% compared bybaseline
Cardiovascular adverse events	12 months after primary PCI	readmission due to heart failure, daeath, myocardial infarction
renal function renal function Renal function	6 months after primary PCI	Glomerular filtration rate evaluated glomerular filtration rate 6 months after primary PCI

Trial Locations

Locations (1)

Chinese PLA general hospital; 🇨🇳 Beijing, Beijing, China