I20 I20-I25
Conditions
Interventions
Group 1: Experimental Arm:
Patients who test negative for Copeptin at admission will be considered low-risk and will be discharged home without further interventions.
To secure the patients safety t
Sponsors
Charité Berlin, Arbeitsbereich Notfallmedizin CVK und CCM
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Admission to the Emergency Department with symptoms consistent with ACS: - Typical chest pain (with or without ECG-changes, but no ST-elevation) suggestive of unstable angina or non-ST-elevated myocardial infarction (NSTEMI) - Troponin negative at admission according to the current clinical practice Patient willing and able to give written informed consent
Exclusion criteria
Exclusion criteria: Patients with ST-elevation myocardial infarction (STEMI) Continuing chest pain or recurrent episodes of chest pain under therapy High-risk patients with suspected ACS who need to be hospitalized for reasons independent of their initial troponin result Patients who need to be hospitalized for other medical reasons Patients in need of urgent life-saving interventions Patients under 18 years of age Patients with a life expectancy < 6 months Patients with any condition that leads the treating physician to not consider the patient eligible for the trial
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Efficiency endpoint of proportion of patients in whom coronary angiography is performed copeptin vs. control arm. Proportion of patients requiring PCI due to their findings in cardiac catheterization copeptin vs. control arm. (Assessment of Copeptin as a rule-in marker) Further secondary endpoints evaluate efficacy, safety, cost effectiveness and patient satisfaction of the new process including length of stay in the hospital. All-cause death, survived sudden cardiac arrest, myocardial infarction, re-hospitalisation for acute coronary syndrome, acute unplanned PCI, coronary artery bypass grafting (CABG) and documented life-threatening arrhythmias (VF, VT, AV-block III) at 30 and 90 days. | — |
Primary
| Measure | Time frame |
|---|---|
| Safety effectivity endpoint: Proportion of MACE (all- cause death or survived sudden cardiac arrest, myocardial infarction, re-hospitalisation for acute coronary syndrome, acute unplanned PCI, coronary artery bypass grafting (CABG) and documented life-threatening arrhythmias (VF, VT, AV-block III)) within 30 days Copeptin vs. Control arm (non-inferiority). | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactJulia Searle
Charité - Universitätsmedizin Berlin Campus Virchow Klinikum Med. Klinik m.S. Kardiologie Internistische Notaufnahme
Outcome results
None listed