cardiac arrhythmias, Heart rhythm disorders, Heart rhythm disturbances cardiac arrhythmias, Heart rhythm disorders, Heart rhythm disturbances
Conditions
Interventions
Implantable cardiac monitor arm vs standard of care arm (control group)
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients = 18 years of age with a recent (= 12 months) STEMI or NSTEMI according to the definition by current ESC/AHA guidelines LVEF >35-=50% measured > 48 hours after index STEMI or NSTEMIIn case a candidate has an LVEF <35% after a recent MI, the responsible physician can decide to treat the patient with GDMT first and reassess the LVEF after 3 months post-MIClinically relevant myocardial scar, identified by one of the following criteria:Post-MI TTE: Akinetic or dyskinetic myocardial segments seen on two anatomically adjacent echocardiographic segments suggestive for ischaemic scar Post-MI ECG: Pathologic Q-waves of =0.04 seconds in duration and =25% of the R wave amplitude in at least two contiguous leads Post-MI MRI: Late gadolinium enhancement (LGE) in a typical ischemic distribution pattern, characterized by subendocardial or transmural involvement in at least one myocardial segment corresponding to a coronary artery territory, and confirmed on two orthogonal imaging planes Post-MI nuclear imaging: Severely reduced perfusion and absent of metabolic activity in two or more contiguous segments, with tracer uptake less than 50%
Exclusion criteria
Exclusion criteria: Patients implanted with any CIED or with a guideline indication for a CIED Indication for chronic renal dialysisPatients with life expectancy shorter than 12 months due to any medical conditionNYHA Class IVParticipation in another trial that may interfereWoman who are pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite of cardiac arrhythmias necessitating medical interventionThis composite endpoint includes all arrhythmia that are registered that prompt a clinical action, which can include, but is not limited to, a change in medication, a diagnostic or interventional procedure or hospitalization. | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortalityCardiovascular mortality Cardiac arrhythmias individually, defined as bradycardia, AF, other SVT, VT, NSVT, VF and PVC burden; with and without interventions Composite of NSVT, VT and VFICD or pacemakers implantations, appropriate ICD therapy Complications related to ICM implantPatient health and safety perception, reported by questionnaires such as the Florida Patient Acceptance Survey (FPAS), self-assessed New York Heart Association (NYHA), and the EQ-5D-5LLevels of NT-proBNP at baseline and during follow-up (if measured during routine clinical follow-up)Levels of CRP, Lp(a), IL-6 at baseline and during follow-up if availableReported COVID infection in historyHealth risk measured as a composite of:Step up of =1 NYHA Class Heart failure admissionsMajor Adverse Cardiac Event (MACE): the composite of cardiovascular mortality, percutaneous coronary intervention (PCI), myocardial infarction (MI) and cerebrovascular accident (CVA) | — |
Countries
Netherlands, United Kingdom, United States
Contacts
Public ContactM Hosny
Amsterdam UMC
Outcome results
None listed