Myocardial Infarct
Conditions
Keywords
ST infarction, PCI, Bisoprolol, Ramipril, Dapagliflozin, Global longitudinal strain (GLS, %)
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 sodium/glucose 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 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
Interventions
DRUGBisoprolol Oral Tablet
Timing of drug intervention after PCI
DRUGRamipril Oral Product
Timing of drug intervention after PCI
DRUGDapagliflozin Oral Product
Timing of drug intervention after PCI
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This prospective, 2x2x2 factorial, randomized, controlled,
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with STEMI who undergo primary PCI within 6 hours of symptom onset (Excluding prodromal symptoms) 2. Informed consent
Exclusion criteria
1. Killip class ≥ 3 2. Chronic kidney disease with GFR \< 25 ml/min/1.73 m2 3. Pre-existing non-reversible cardiac dysfunction or heart failure 4. Current treatment with any beta blocker, RAAS inhibitor or SGLT2 inhibitor 5. Absolute or relative contraindication to any one of the study drugs that confers a risk of patient safety if the patient participates in the trial and adheres to the protocol-specified recommendations, per the assessment of the treating physician 6. Life expectancy less than one year 7. Pregnancy or women of childbearing potential who is not sterilized or is not using a medically accepted form of contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Global longitudinal strain (GLS, %) | day 7±24 hours | GLS adjusted for baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Left ventricular ejection fraction (LVEF) | day 7±24 hours | LVEF adjusted for baseline |
| Measurement of NT-proBNP (N-terminal pro b-type natriuretic peptide ) | day 7±24 hours | NT-proBNP adjusted for baseline |
| Concentration of cardiac troponin-T | Day 30 | Area under the curve |
| Concentration of cardiac troponin-I | Day 30 | Area under the curve |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Infarct size | Day 30 | MI size assessed by CMRI (sub-study) |
Countries
Sweden
Contacts
Primary ContactBjörn Redfors, Professor
Backup ContactMargareta Scharin Täng, PhD
Outcome results
None listed