BIOGUARD-MI

BIO Monitoring in Patients with Preserved Left Ventricular Function After Diagnosed Acute Myocardial Infarction

Randomized, controlled, parallel-group, open, prospective, multi-center, international study
Investigates whether the early diagnosis of cardiac arrhythmias, provided by the BioMonitor in connection with remote monitoring, and the consequent treatment of the patient will decrease the risk to experience a major adverse cardiovascular event (MACE) in patients with AMI, LVEF > 35 % and modified CHADS2-score ≥ 3
2,900 patients planned – This study is ongoing

1° Endpoints	Time to first major cardiac adverse event (MACE) MACE is defined as death for cardiovascular reasons or unplanned hospitalization for cardiovascular reasons
Sample Size	2,900 patients
Inclusion Criteria	History of AMI according to guidelines CHADS2-score ≥ 3 with modified age-variable ≥ 65 years LVEF > 35 % Patient accepts activation of Home Monitoring® Patient has provided written informed consent
Main Exclusion Criteria	Platelet count 3 or patients with haemorrhagic diathesis Permanent oral anticoagulation treatment for atrial fibrillation Indication for chronic renal dialysis Pacemaker or ICD implanted or indication for implantation Previously documented sustained VT Parkinson's disease Life expectancy Participation in another interventional clinical investigation
Devices	BioMonitor or CE-approved successors
Follow-Up	Depending on date of enrollment from 2 until 6 years
Study Duration	study start date Aug 2015 - 6 years planned
Reference no.	NCT02341534
Steering Committee	Dr. Christian Jons (Rigshospitalet, Denmark) Prof. Dietmar Bänsch (Universitätsmedizin Rostock, Germany) Professor Peter Sogaard (Aalborg University Hospital, Denmark) Prof. Poul Erik Bloch Thomsen (Denmark)

BIOTRONIK offers accurate arrhythmia detection with Insertable Cardiac Monitors.