BETAMI studien: Behandling med eller uten betablokkere hos pasientermed hjerteinfarkt

Phase 1

• Conditions: Patients admitted to hospital with acute myocardial infarction treated With reperfusion therapy (i.e trombolysis or percutaneous coronary intervention); Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-000590-75-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-06
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 5000

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
F.1.3.1 Number of subjects for this age range 2500

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
o Severe peripheral artery disease
o Previously known side-effects causing withdrawal
o Severe chronic obstructive pulmonary disease
o Others, according to the responsible investigator
• Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible
• Women of childbearing potential using inadequate birth control, pregnancy, and/or breastfeeding. Adequate contraception includes oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or system, vasectomized partner or sexual abstinence.
• Short life expectancy due to other medical conditions
Previous treatment with a BB is not an exclusion criterion for enrollment into the BETAMI study.

Study & Design

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