STunning in Acute Myocardial Infarction - BAS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bisoprolol Oral Tablet, Ramipril Oral Product, Dapagliflozin Oral Product.
- Who it may be relevant to
- Registry conditions: Myocardial Infarct. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
STunning in Acute Myocardial Infarction - Beta Blockers, Angiotensin Converting Enzyme Inhibitors and Sodium/Glucose Cotransporter 2 Inhibitors Trial A Low Intervention Clinical Tria
Overview
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
- Drug Bisoprolol Oral Tablet
Timing of drug intervention after PCI - Drug Ramipril Oral Product
Timing of drug intervention after PCI - Drug Dapagliflozin Oral Product
Timing of drug intervention after PCI
Primary outcome measures
- Measurement of Global longitudinal strain (GLS, %) [Time frame: day 7±24 hours]
Secondary outcome measures (4)
- Measurement of Left ventricular ejection fraction (LVEF) [Time frame: day 7±24 hours]
- Measurement of NT-proBNP (N-terminal pro b-type natriuretic peptide ) [Time frame: day 7±24 hours]
- Concentration of cardiac troponin-T [Time frame: Day 30]
- Concentration of cardiac troponin-I [Time frame: Day 30]
Eligibility criteria
Inclusion criteria
- Patients with STEMI who undergo primary PCI within 6 hours of symptom onset (Excluding prodromal symptoms)
- Informed consent
Exclusion criteria
- Killip class ≥ 3
- Chronic kidney disease with GFR < 25 ml/min/1.73 m2
- Pre-existing non-reversible cardiac dysfunction or heart failure
- Current treatment with any beta blocker, RAAS inhibitor or SGLT2 inhibitor
- 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
- Life expectancy less than one year
- Pregnancy or women of childbearing potential who is not sterilized or is not using a medically accepted form of contraception
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Sahlgrenska University Hospital — Gothenburg
Identifiers
NCT: NCT06562582 · 2024-511789-35-00