The objective of this trial is to examine the effect of immediate versus late administration of beta blockers, angiotensin converting enzyme inhibitors (ACEI), and sodium/glucose cotransporter 2 (SGLT2) inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction (STEMI)
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 sodium/glucose 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 7±24 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Timing of drug intervention after PCI
Timing of drug intervention after PCI
Timing of drug intervention after PCI
Sahlgrenska University Hospital
Gothenburg, Sweden
RECRUITINGMeasurement of Global longitudinal strain (GLS, %)
GLS adjusted for baseline.
Time frame: day 7±24 hours
Measurement of Left ventricular ejection fraction (LVEF)
LVEF adjusted for baseline
Time frame: day 7±24 hours
Measurement of NT-proBNP (N-terminal pro b-type natriuretic peptide )
NT-proBNP adjusted for baseline
Time frame: day 7±24 hours
Concentration of cardiac troponin-T
Area under the curve
Time frame: Day 30
Concentration of cardiac troponin-I
Area under the curve
Time frame: Day 30
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