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LOW-DOSE DOBUTAMINE INFUSION AND SINGLE-DOSE TOCILIZUMAB IN ACUTE MYOCARDIAL INFARCTION PATIENTS WITH HIGH RISK OF CARDIOGENIC SHOCK DEVELOPMENT (DOBERMANN)
EU CTIS ID: 2024-515999-13-00
What this study is testing
In the present study, we aim to investigate the effects of dobutamine infusion and/or a single post-PCI intravenous (IV) dose of Tocilizumab on plasma concentration of NTproBNP as a proxy for development of hemodynamic instability / CS in patients with acute myocardial infarction (AMI) presenting < 24 hours from chest pain plus intermediate to high risk of CS assessed by the ORBI risk score (≥11 – not in overt shock at hospital admission).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Acute myocardial infarction
- Revascularization with PCI
- Presentation within 24 hours of chest pain
- ORBI risk score ≥ 10
- Age ≥ 18 years
You likely can't join if
- Comatose after cardiac arrest
- Immune deficiency/treatment with immunosuppressants
- Known, uncontrolled gastrointestinal (GI) disease predisposing to GI perforation
- Unwilling to give informed consent to study participation
- Unable to give consent due to language barrier
- 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.
See the full eligibility criteria
- Acute myocardial infarction
- Revascularization with PCI
- Presentation within 24 hours of chest pain
- ORBI risk score ≥ 10
- Age ≥ 18 years
- Comatose after cardiac arrest
- Immune deficiency/treatment with immunosuppressants
- Known, uncontrolled gastrointestinal (GI) disease predisposing to GI perforation
- Unwilling to give informed consent to study participation
- Unable to give consent due to language barrier
- 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, whereas subacute (>24 hours will be included)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.