E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
successful percutaneous intervention in patients with acute ST-elevated myocardial infarct
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E.1.1.1 | Medical condition in easily understood language |
successful dilatation of heart vessels after acute ST-elevated myocardial infarct
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Maximal increase of Troponin T concentration over 48 hours after the baseline value
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E.2.2 | Secondary objectives of the trial |
• 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) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Acute st-segment elevation myocardial infarction (time between symptom onset and PCI < 6 hours) with successful PCI (TIMI III°) • Killip Klassification I, II • Written informed consent • Resting heart rate ≥ 60 bpm • Age above 18 years • Mean blood pressure ≥ 65 mmHg • Systolic blood pressure > 90mmHg • Medication with Heparin (weight adapted), clopidogrel ans aspirin before PCI • SO2 > 90% • Elevated heart rate (≥ 60/min) |
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E.4 | Principal exclusion criteria |
• Mean blood pressure < 65 mmHg • Incomplete PCI success (TIMI < III) • Cardiogenic shock • Killip Klassification III, IV • Symptomatic AV conduction block II°, III° • Catecholamin therapy • Heart rate < 60/min. • Severe peripheral artery disease (Fontaine > IIb) • Moderate to severe renal impairment (Serum-creatinin > 2 mg/100ml) • Severe liver dysfunction • Severe acidosis (pH < 7,2) • Known contraindications for Brevibloc (e.g. asthma bronchiale) or known intolerance to Brevibloc • Participation in other interventional studies • Person related to the sponsor or investigator • Unterbringung in einer Anstalt aufgrund gerichtlicher oder behördlicher Anordnung • Subjects who were not eligible for follow-up visits (e.g. due to long distance between study hospital and home adress) • Women in whom a pregnancy cannot excluded • Missing safe contraception (hormonal or copper spirale) • Patients without guidelines recommended therapy previosly to PCI • Patients in whom anamnestic the symptom onset was > 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Maximal increase of the Troponin-T-concentration over 48 h after baseline value. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The Troponin values will be determined 1, 6, 12, 24 and 48 hours post AMI. |
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E.5.2 | 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) |
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E.5.2.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of Trial: last visit of the last subject undergoing the trial.
The treatment and aftertreatment of the patients with a myocardial infarct will be done concerning the internal guidances of the clinic III internal medicine, which are orientated at the effective guidances of the German and European society of Cardiology.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |