Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05770687
Status:
RECRUITING
Last Update Posted:
2023-03-15
First Post:
2023-03-05
Brief Title:
SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients With Acute Myocardial Infarction a Prospective Multi-center Registry Study
Sponsor:
Kiyuk Chang
Organization:
Seoul St Marys Hospital
Study Overview
Official Title:
Real World Observation of SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients With Acute Myocardial Infarction a Prospective Multi-center Registry Study
Status:
RECRUITING
Status Verified Date:
2023-03
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:
RECORD-AMI
Brief Summary:
Prospective trials performed on type 2 diabetes patients without established cardiovascular disease has shown that SGLT2 inhibitors reduce cardiovascular risk No studies have yet examined the occurrence of cardiovascular disease in patients with acute myocardial infarction
The investigators designed the current study to evaluate the most ideal oral hypoglycemic agent in type 2 diabetes patients undergoing percutaneous coronary intervention for acute myocardial infarction The investigators hypothesize that the use of SGLT-2 inhibitors will reduce cardiovascular events and modify left ventricular remodeling after myocardial infarctions
The investigators designed the current study to evaluate the most ideal oral hypoglycemic agent in type 2 diabetes patients undergoing percutaneous coronary intervention for acute myocardial infarction The investigators hypothesize that the use of SGLT-2 inhibitors will reduce cardiovascular events and modify left ventricular remodeling after myocardial infarctions
Detailed Description:
8 hospitals of the Catholic University of Korea with high-volume percutaneous coronary intervention of following hospitals are participating in the current study
Seoul St Marys Hospital Seoul South Korea
Yeoido St Marys Hospital Seoul South Korea
Uijongbu St Marys Hospital Gyeonggi-do South Korea
Eunpyeong St Marys Hospital Seoul South Korea
Bucheon St Marys Hospital Gyeonggi-do South Korea
Incheon St Marys Hospital Incheon South Korea
St Vincent Hospital Gyeonggi-do South Korea
Daejeon St Marys Hospital Daejeon South Korea
After recruitment of all patients the control group will be selected from a previous prospective cohort COREA-AMI NCT02385682 using identical inclusion exclusion criteria except for use of SGLT2 inhibitors The control cohort of 3000 patients will be selected using 13 propensity matching
Seoul St Marys Hospital Seoul South Korea
Yeoido St Marys Hospital Seoul South Korea
Uijongbu St Marys Hospital Gyeonggi-do South Korea
Eunpyeong St Marys Hospital Seoul South Korea
Bucheon St Marys Hospital Gyeonggi-do South Korea
Incheon St Marys Hospital Incheon South Korea
St Vincent Hospital Gyeonggi-do South Korea
Daejeon St Marys Hospital Daejeon South Korea
After recruitment of all patients the control group will be selected from a previous prospective cohort COREA-AMI NCT02385682 using identical inclusion exclusion criteria except for use of SGLT2 inhibitors The control cohort of 3000 patients will be selected using 13 propensity matching
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