BEta-Blocker Treatment after Acute Myocardial Infarction inrevascularized patients with preserved left ventricular systolic function(BETAMI trial)

Oslo University Hospital0 个研究点目标入组 5,000 人开始时间: 2018年3月6日最近更新: 2021年6月28日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Oslo University Hospital