EUCTR2018-000590-75-NO
Active, not recruiting
Phase 1
BEta-Blocker Treatment after Acute Myocardial Infarction inrevascularized patients with preserved left ventricular systolic function(BETAMI trial)
Oslo University Hospital0 sites5,000 target enrollmentMarch 6, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients admitted to hospital with acute myocardial infarction treated With reperfusion therapy (i.e trombolysis or percutaneous coronary intervention)
- Sponsor
- Oslo University Hospital
- Enrollment
- 5000
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years or older
- •Diagnosed with an acute MI type I according to the Universal Definition of MI (Defined as a detection of a rise and/or fall of cardiac biomarker value, preferably troponin, with at least one value above the 99th percentile upper reference limit and with at least one of the following; a) symptoms of ischemia, b) new or presumed new significant ST\-segment\-T wave changes or new left bundle branch block, c) development of pathological Q waves, d) imaging evidence of new loss of viable myocardium or e) identification of an intracoronary thrombus by CAG)
- •Must have been treated with PCI or thrombolysis during current hospitalization
- •Signed informed consent and expected cooperation of the patient according to ICH/GCP and national/local regulations
- •Have a national personal identification number and not be expected to emigrate during study
- •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 2500
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Study subjects must not meet any of the following criteria:
- •Having a condition where BB\-therapy is required, including but not limited to:
- •o Arrhythmias
- •o Hypertension
- •o Cardiomyopathies
- •o Clinical diagnosis of heart failure
- •o LVEF \< 40% by echocardiography
- •Contraindications to BB\-therapy:
- •o Bradyarrhythmias
- •o Hypotension
Outcomes
Primary Outcomes
Not specified
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