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

Heart Failure Clinical Trial

— Health  

Official title:

Clinical Study on Reducing Myocardial Infarction Siez After Primary PCI in Patients With ST Segment Elevation Myocardial Infarction by Using Henagliflozin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06187727
• Other study ID #: Henagliflozin for infarction
• Secondary ID: Z-2017-26-2202-0
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: November 2023
• Source: Chinese PLA General Hospital
• Contact: Geng Qian, MD
• Phone: 086-13371665688
• Email: qiangeng9396[@]263.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Henagliflozin
After primary PCI, Henggliflozin or Placebo was administered within 24 hours, followed by daily oral administration until 6 months post-acute myocardial infarction.

Locations

Country	Name	City	State
China	Chinese PLA general hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Qian geng

Country where clinical trial is conducted

China, 

References & Publications (5)

Andreadou I, Efentakis P, Balafas E, Togliatto G, Davos CH, Varela A, Dimitriou CA, Nikolaou PE, Maratou E, Lambadiari V, Ikonomidis I, Kostomitsopoulos N, Brizzi MF, Dimitriadis G, Iliodromitis EK. Empagliflozin Limits Myocardial Infarction in Vivo and C — View Citation

Lee TM, Chang NC, Lin SZ. Dapagliflozin, a selective SGLT2 Inhibitor, attenuated cardiac fibrosis by regulating the macrophage polarization via STAT3 signaling in infarcted rat hearts. Free Radic Biol Med. 2017 Mar;104:298-310. doi: 10.1016/j.freeradbiome — View Citation

Mizuno M, Kuno A, Yano T, Miki T, Oshima H, Sato T, Nakata K, Kimura Y, Tanno M, Miura T. Empagliflozin normalizes the size and number of mitochondria and prevents reduction in mitochondrial size after myocardial infarction in diabetic hearts. Physiol Rep — View Citation

Stone GW, Selker HP, Thiele H, Patel MR, Udelson JE, Ohman EM, Maehara A, Eitel I, Granger CB, Jenkins PL, Nichols M, Ben-Yehuda O. Relationship Between Infarct Size and Outcomes Following Primary PCI: Patient-Level Analysis From 10 Randomized Trials. J A — View Citation

Tanajak P, Sa-Nguanmoo P, Sivasinprasasn S, Thummasorn S, Siri-Angkul N, Chattipakorn SC, Chattipakorn N. Cardioprotection of dapagliflozin and vildagliptin in rats with cardiac ischemia-reperfusion injury. J Endocrinol. 2018 Feb;236(2):69-84. doi: 10.153 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of myocardial enzymes (CK-MB)	Postoperative dynamic monitoring of myocardial enzyme (CK-MB)changes post infarction	3 days after the primary PCI
Secondary	Left ventricular remodeling	Left ventricular remodeling evaluated by echocardiography,left ventricular end diastolic volume increase more than 20% compared bybaseline	6 months after primary PCI
Secondary	contrast induced by nephropathy	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.	5 days after the primary PCI
Secondary	Cardiovascular adverse events	readmission due to heart failure, daeath, myocardial infarction	12 months after primary PCI
Secondary	renal function renal function Renal function	Glomerular filtration rate evaluated glomerular filtration rate 6 months after primary PCI	6 months after primary PCI
Secondary	Infarct size	Infarct size measured by cardiac magnetic resonance imaging	7 days after the primary PCI