Skip to content
Home » Sample Page » BIO GUARD – MI


  • by

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

  • Rationale – despite modern optimal therapy, a large proportion of patients remain at high risk for MACE following MI
  • 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

Number of Canberra Heart Rhythm patients involved in BIO GUARD – MI Study: 4

InclusionHistory 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 treatmentExclusionPlt < 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

Leave a Reply

Your email address will not be published. Required fields are marked *