BIO|GUARD - MI

Monitoring in patients with preserved left ventricular function After Diagnosed acute Myocardial Infarction

Terminated study, the number of patients recruited: 4

  • Rationale – despite modern optimal therapy, a large proportion of patients remain at high risk for Major Adverse Cardiac Event (MACE) following myocardial infarction
  • Implantable cardiac monitors (ICM) have shown up to 80% of patients experience an arrhythmia prior to MACE in MI with reduced EF ≤ 40% – CARISMA trial (n=297, mean 2yr f/u)
  • Objective: whether early diagnosis of cardiac arrhythmias, with ICM and remote monitoring, and its consequent treatment, reduce MACE
  • Prospective, randomised (1:1), parallel-group, open trial;
 
Primary composite endpoint:
 
  • Time to first MACE – cardiovascular death, first acute unscheduled hospitalisation or urgent visit for worsening of patient status due to heart failure
  • First acute unscheduled visit for:
    • Arrhythmia
    • ACS
    • Stroke
    • Major bleeding
    • Systemic embolism
Secondary endpoints:
 
  • primary composite points separately, WHO-5 well-being index

 

Inclusion criteria

  • History of AMI,
  • CHADSVASc ≥ 4 in men, and ≥ 5 in women,
  • LVEF > 35% as estimated within 6 months prior to enrolment, but after conclusion of AMI treatment
Exclusion criteria
 
  • Plt < 90,000 per mm 3 or with bleeding diathesis,
  • permanent oral anticoagulation for AF,
  • indication for renal dialysis,
  • indication for PPM,
  • Parkinson’s disease,
  • life expectancy < 1 yr,
  • pregnant or breast feeding

 

Used systems – BioMonitor or CE-approved successors, Renamic or ICS 3000, home monitoring CardioMessenger II and above with remote assistant

bioguard mi diagram