Low-Dose Dobutamine and Single-Dose Tocilizumab in Acute Myocardial Infarction With High Risk of Cardiogenic Shock

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

In the present study, we aim to investigate the effects of dobutamine infusion and/or a single intravenous (IV) dose of the IL-6 antagonist Tocilizumab administered after percutaneous coronary intervention (PCI) to patients with acute myocardial infarction (AMI) presenting < 24 hours from onset of chest pain and an intermediate to high risk of cardiogenic shock (CS) by assessment with the ORBI risk score (≥11 - not in overt shock at hospital admission).

Plasma concentrations of N-terminal pro-B-type natriuretic peptide (NTproBNP) as a proxy for development of cardiogenic shock (CS) and hemodynamic instability will be sampled for primary endpoint analysis.

Effects on clinical parameters, mortality, morbidity as well as specific indicators of inflammation, cardiac function, and infarct size will secondarily be assessed noninvasively.

The rationale behind the current study is that inflammatory and neurohormonal responses are associated with subclinical hemodynamic instability in patients with AMI with high risk of CS have worse outcomes. The potentially unstable condition may be targeted pharmacologically as an add-on to existing therapy. This is investigated in patients at elevated risk of CS by sampling biomarkers reflecting the inflammatory and neurohormonal responses, as well as determining effects on patient outcomes and infarct size.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborators: Helge Peetz og Verner Peetz og hustru Vilma Peetz Legat; Novo Nordisk A/S; Simon Spies Fonden
• Treatments: Dobutamine

Criteria

Inclusion Criteria:

• Acute myocardial infarction

• Revascularization with PCI

• Presentation within 24 hours of chest pain

• ORBI risk score ≥ 11

• Age ≥ 18

Exclusion Criteria:

• Unwilling to give informed consent to study participation

• Unable to give consent due to language barrier

• Comatose after cardiac arrest

• Cardiogenic shock with systolic blood pressure < 100 mmHg for more than 30 minutes or need for vasopressor to maintain blood pressure and arterial lactate > 2,5 (2,0) mmol/L developed before leaving the cath. lab.

• Other major clinical non-coronary condition (stroke, sepsis etc.), which can explain a high ORBI risk score

• Referral for acute coronary artery bypass grafting (CABG) (< 24 hours) after the CAG

• Contraindications against dobutamine infusion (sustained ventricular tachycardia prior to admission or noted in the cath.lab., known pheochromocytoma, idiopathic hypertrophic subaortic stenosis)

• Tocilizumab allergy

• Pregnant- or breastfeeding women

• Known liver disease/dysfunction

• Ongoing uncontrollable infection

• Immune deficiency/treatment with immunosuppressants

• Known, uncontrolled gastrointestinal (GI) disease predisposing to GI perforation