Health TrialsbyHealthPanel

STunning in Acute Myocardial Infarction - BAS

ConditionMyocardial Infarct
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with STEMI who undergo primary PCI within 6 hours of symptom onset (Excluding prodromal symptoms)

Informed consent

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Bisoprolol Oral Tablet

    Drug

    Timing of drug intervention after PCI

  • Ramipril Oral Product

    Drug

    Timing of drug intervention after PCI

  • Dapagliflozin Oral Product

    Drug

    Timing of drug intervention after PCI

Treatment groups

120 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: BisoprololActive comparator 1 intervention
Group B: No BisoprololNo intervention 0 interventions
Group C: RamiprilActive comparator 1 intervention
Group D: No RamiprilNo intervention 0 interventions
Group E: DapagliflozinActive comparator 1 intervention
Group F: No DapagliflozinNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Measurement of Global longitudinal strain (GLS, %)

GLS adjusted for baseline.

Time frame
day 7±24 hours

Secondary outcomes

1

Measurement of Left ventricular ejection fraction (LVEF)

LVEF adjusted for baseline

Time frame
day 7±24 hours
2

Measurement of NT-proBNP (N-terminal pro b-type natriuretic peptide )

NT-proBNP adjusted for baseline

Time frame
day 7±24 hours
3

Concentration of cardiac troponin-T

Area under the curve

Time frame
Day 30
4

Concentration of cardiac troponin-I

Area under the curve

Time frame
Day 30

Other outcomes

1

Measurement of Infarct size

MI size assessed by CMRI (sub-study)

Time frame
Day 30

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

Source ClinicalTrials.gov
Apply now