Acute myocardial infarction MedDRA version: 9.1 Level: LLT Classification code 10028596 Term: Myocardial infarction
Conditions
Interventions
Product Name: BQ-123
Product Code: BQ-123
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Sponsors
Medical University of Vienna, Department of Internal Medicine II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This study includes STEMI patients (defined as: Evidence of ischemic chest pain for >30 minutes within 1mm and/or elevated serum creatine phosphokinase or twofold elevation of troponin-T), aged 18 years and above, who undergo primary percutaneous revascularization (PCI) and have confirmed initial TIMI 0 or 1 in the infarct related coronary artery. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria • Significant liver disease • History of prior myocardial infarction • Current atrial fibrillation • History of congestive heart failure • History of migraine headache • Significant valvular heart disease, primary myocardial disease • Cardiogenic shock (sRR <90mmHg or need for inotropic support) • Child-bearing potential • Inability to read, understand and sign the informed consent • Life expectancy <3y • Participation in another clinical study • Metal implants contraindicating CMR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the present study is to investigate the effect of ET–receptor blockade by BQ-123 on myocardial perfusion and infarct size as an adjunct to PCI-reperfusion therapy in patients with STEMI.;Secondary Objective: ;Primary end point(s): Myocardial perfusion determined by CMR | — |
Countries
Austria
Outcome results
None listed