Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562582
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
STunning in Acute Myocardial Infarction - BAS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
STunning in Acute Myocardial Infarction - Beta Blockers Angiotensin Converting Enzyme Inhibitors and SodiumGlucose Cotransporter 2 Inhibitors Trial A Low Intervention Clinical Tria
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAMI-BAS
Brief Summary:
The objective of this trial is to examine the effect of immediate versus late administration of beta blockers angiotensin converting enzyme inhibitors ACEI and sodiumglucose cotransporter 2 SGLT2 inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction STEMI
Detailed Description:
Left ventricular LV remodeling after ST-elevation myocardial infarction STEMI is associated with poor outcomes but the mechanisms underlying adverse LV remodeling are poorly understood It is also poorly understood how current guideline-recommended treatments affect early LV remodeling This low interventional clinical trial will compare the effects of early versus late initiation of the three pharmacotherapies on early LV remodeling and cardiometabolic profiles
Trial objective
The objective of this trial is to examine the effect of immediate versus late administration of beta blockers angiotensin converting enzyme inhibitors ACEI and sodiumglucose cotransporter 2 SGLT2 inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction STEMI
Primary endpoint
Global longitudinal strain GLS at day 724 hours after PCI adjusted for baseline day 0 GLS
Trial design
This prospective 2x2x2 factorial randomized controlled open-label low intervention clinical trial will enroll subjects with STEMI who undergo primary percutaneous coronary intervention PCI within 6 hours of symptom onset
Trial population
Patients over the age of 18 with STEMI who undergo primary PCI
Trial objective
The objective of this trial is to examine the effect of immediate versus late administration of beta blockers angiotensin converting enzyme inhibitors ACEI and sodiumglucose cotransporter 2 SGLT2 inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction STEMI
Primary endpoint
Global longitudinal strain GLS at day 724 hours after PCI adjusted for baseline day 0 GLS
Trial design
This prospective 2x2x2 factorial randomized controlled open-label low intervention clinical trial will enroll subjects with STEMI who undergo primary percutaneous coronary intervention PCI within 6 hours of symptom onset
Trial population
Patients over the age of 18 with STEMI who undergo primary PCI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None