BIO monitorinG in patients with preserved left ventricUlar function AfteR Diagnosed Myocardial Infarction Grant uri icon

abstract

  • The BIO GUARD-MI study is a multicenter, prospective, randomized (1:1), controlled, parallel-group, open, international study with an event - driven design. The study was divided into two phases. The US sties will be joining the second phase of the study. At the time of submission of the US study protocol the gate to enter the second phase (20 endpoints reached) was estimated by the main sponsor after blinded review of cardiovascular SAEs. After the Endpoint an Adverse Event Committee (EAEC) has officially adjudicated that 20 subjects have reached an endpoint a statement will be prepared to announce the official start of the second phase of the study. The second phase is currently planned to last until approximately 2021. The study includes an enrollment-assessment and randomization procedure. The randomization is 1:1, either in the BioMonitor group (subjects are implanted with the BioMonitor) or in the control group (subjects do not receive a device). The qualifying measurement of the LVEF should be from the time after conclusion of the acute treatment of the most recent MI, but not older than 6 months. For subjects randomized to the BioMonitor group, the implant shall be performed as soon as possible, but no more than 8 weeks after enrollment. Most study procedures will typically take place during the index hospitalization (enrollment, implantation if applicable and discharge). Following discharge, subjects will be treated according to clinical routine/guidelines. Hence, no study specific pre-planned procedures will be performed. Subjects should contact their general practitioner (GP) or cardiologist as in standard post-MI care as needed for their care or in the event of any new symptoms. To assess the primary endpoint, all subjects will receive telephone calls every 6 months and will be interviewed by means of a questionnaire. these phone calls will be conducted in a way as not to interfere in the normal health care, i.e. the subject will receive no medical advice of any kind but will only be asked about events of the preceding period. Additionally, subjects who are randomized to the BioMonitor group by be contacted and scheduled for a visit when an arrhythmia was detected by the BioMonitor, if the investigator considers this clinically indicated. The follow-up period of the individual subject is dependent on the time of entry into the study. All subjects will be followed until the number of needed endpoints for the final analysis is reached or the DSMB determines a premature study termination. Thereafter, the formal study termination is announced and all subjects will receive a final telephone call to inform them about the study end and, if applicable, to schedule the study termination visit. .

date/time interval

  • July 2019 - June 2021