Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2025-12-16 @ 9:29 PM
Study NCT ID:
NCT06187727
Status:
None
Last Update Posted:
2025-12-02 00:00:00
First Post:
2023-12-17 00:00:00
Brief Title:
Henagliflozin Reducing Infarct Size After Priamry PCI in Patients With ST Segment Elevation Myocardial Infarction
Sponsor:
Qian geng
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
Clinical Study on Reducing Myocardial Infarction Siez After Primary PCI in Patients With ST Segment Elevation Myocardial Infarction by Using Henagliflozin
Status:
None
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Health
Brief Summary:
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).
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Z-2017-26-2202-04 | OTHER_GRANT | China International Medical Fundinging | None |