successful percutaneous intervention in patients with acute ST-elevated myocardial infarct
Conditions
Interventions
Trade Name: Brevibloc
Pharmaceutical Form: Infusion
CAS Number: 81161-17-3
Current Sponsor code: Esmololhydrochlorid
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concen
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Acute st-segment elevation myocardial infarction (time between symptom onset and PCI 90mmHg • Medication with Heparin (weight adapted), clopidogrel ans aspirin before PCI • SO2 > 90% • Elevated heart rate (= 60/min) Are the trial subjects under 18? no Number of subjects for this age range: 0 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: • Mean blood pressure IIb) • Moderate to severe renal impairment (Serum-creatinin > 2 mg/100ml) • Severe liver dysfunction • Severe acidosis (pH 6 hours or first laboratory tests indicate (LDH > 280U/I) that the myocardial infarction onset was more than 6 hours and in whom no other reasons for elevated LDH are present. • Unsuccessful PCI • Symptom onset > 6 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Maximal increase of Troponin T concentration over 48 hours after the baseline value ;Secondary Objective: • Endothelial Progenitor cells (EPC) • NT-proBNP • Re-incidence of Angina Pectoris • Re-hospitalisation • Re-heart catheter • Re-myocardial infarction • Re-intervention • overall mortality • LVEF (transthorakal echokardiography) • Neuropsychological status (VAS) • Quality of life (on basis of EQ5-D questionnaire);Primary end point(s): Maximal increase of the Troponin-T-concentration over 48 h after baseline value.;Timepoint(s) of evaluation of this end point: The Troponin values will be determined 1, 6, 12, 24 and 48 hours post AMI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Endothelial Progenitor cells (EPC) • NT-proBNP • Re-incidence of Angina Pectoris • Re-hospitalisation • Re-heart catheter • Re-myocarial infarct • Re-intervention • overall mortality • LVEF (Transthorakal Echokardiography) • Neuropsychological State (VAS) • Quality of life (on basis of EQ5-D questionnaire);Timepoint(s) of evaluation of this end point: All other target parameters will be determined 6 weeks and 6 months after finishing of the patient-individual 24 hours intervention respectively by an blinded investigator. The EPC-determination will be done by a blinded investigator by FACS (Fluorescence Activated Cell Sorting) and the NT-proBNP measurements will be done in the central laboratory of the university of Cologne. | — |
Countries
Germany
Contacts
Public ContactPriv.-Doz. Dr. Er
University of Cologne
Outcome results
None listed