Heart Failure, Myocardial Infarction
Conditions
Keywords
myocardial infartction, Ventricular remodeling
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).
Interventions
DRUGHenagliflozin
After primary PCI, Henggliflozin or Placebo was administered within 24 hours, followed by daily oral administration until 6 months post-acute myocardial infarction.
Sponsors
Qian geng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| Infarct size | 7 days after the primary PCI | Infarct size measured by cardiac magnetic resonance imaging |
Countries
China
Outcome results
None listed