Acute Myocardial Infarction with increased risk of Cardiogenic Shock. MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Tocilizumab
CAS Number: 375823-41-9
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Department of Cardiology, Copenhagen University Hospital Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acute myocardial infarction; Revascularization with PCI; Presentation within 24 hours of chest pain; ORBI risk score = 11; Age = 18. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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 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 will be included) ; In patients with coronary biomarkers without dynamic elevation (‘rise-and-fall’) reflecting other condition than AMI, treatment with the assigned study drug(s) will be completed and the patient will be included in sensitivity analyses but will not have MRi performed; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In the present study, we aim to investigate the effects of dobutamine infusion and a or 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).;Secondary Objective: The secondary objectives of this study are to determine the effects on development of in-hospital CS and/or in-hospital cardiac arrest and/or transfer to the ICU during index admission, infarct size measured by cMRi, long-term all-cause mortality, biomarkers reflecting neurohormonal activation, endothelial function/damage, inflammation, connective tissue damage, organ dysfunction, PCI operators post-procedure clinical assessment of the patient, development of non-cardiac arrest arrythmia, 2D echocardiographic findings of hemodynamics and left ventricular function, re-admission during the first year after index hospitalization, re-admission with heart failure and re-infarction, SOFA score, quality of life and mental and cognitive health at baseline and after three months.;Primary end point(s): NTproBNP in blood samples drawn from hospital admission to 48 hours after admission.;Timepoint(s) of evaluation of this end point: NTproBNP will be measured on admission and at 3, 12, 24, 36 and 48 hours from admission. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Paraclinical endpoints: Infarct size measured by cMRi during index admission and after 3 months; Biomarkers reflecting neurohormonal activation, endothelial function/damage, inflammation (pro- and anti-inflammatory processes – including IL-6 and C-reactive peptide (CRP)), connec-tive tissue damage, organ dysfunction, and other relevant processes; 2D echocardiographic measurements of hemodynamics (VTI) and left ventricular function including strain measurements according to protocol; SOFA score (PaO2, FiO2, on medical ventilation, Platelets, GCS, Bilirubin, mean arterial pressure OR administration of vasoactive agents required, Creatinine, COVID-19 status). Clinical endpoints: Development of in-hospital CS and/or in-hospital cardiac arrest and/or transfer to the ICU during index admission; Long-term all-cause mortality; PCI operator’s post-procedure clinical assessment of the patient (survives to discharge ‘yes/no’); Development of non-cardiac arrest arrythmia (sustained ventricular tachycardia, atrial fibrillation with a frequency above 120 for more than 30 minutes) during index admission (safety); Re-admission (all cause and cardiovascular) during the first year after index hospitalization; Re-admission with heart failure and re-infarction during the first year after index hospitalization; Quality of Life and mental and cognitive health at baseline and after three months.;Timepoint(s) of evaluation of this end point: Evaulation of paraclinical endpoints during index admission. Evaluation of paraclinical endpoints at follow-up at 3 months. | — |
Countries
Denmark
Contacts
Public ContactKlinisk Forskningsenhed
Department of Cardiology, Copenhagen University Hospital Rigshospitalet
Outcome results
None listed