Heart rate control after acute myocardial infarct

• Conditions: successful percutaneous intervention in patients with acute ST-elevated myocardial infarct; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-000911-26-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-13
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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)
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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified