Clinical trial NCT06562582: STunning in Acute Myocardial Infarction - BAS
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Myocardial Infarct
Keywords: ST infarction
PCI
Bisoprolol
Ramipril
Dapagliflozin
Global longitudinal strain (GLS, %)
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2024-08-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This prospective, 2x2x2 factorial, randomized, controlled,
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of Global longitudinal strain (GLS, %)
timeFrame: day 7±24 hours
Secondary outcomes:
measure: Measurement of Left ventricular ejection fraction (LVEF)
timeFrame: day 7±24 hours
measure: Measurement of NT-proBNP (N-terminal pro b-type natriuretic peptide )
timeFrame: day 7±24 hours
measure: Concentration of cardiac troponin-T
timeFrame: Day 30
measure: Concentration of cardiac troponin-I
timeFrame: Day 30
Other outcomes:
measure: Measurement of Infarct size
timeFrame: Day 30
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References: