Atrial Fibrillation New Onset, Myocardial Infarction
Conditions
Keywords
atrial fibrillation, myocardial infarction, intensive monitoring, oral anticoagulation, hospitalization
Brief summary
After a myocardial infarction (MI), patients discharged home in sinus rhythm may develop AF that is asymptomatic, undetected, and undertreated. Previous studies (CARISMA and ARREST) have demonstrate high rates of new-onset AF recorded on implantable loop recorder (ILR), although the routine implantation of ILRs post-MI remains costly and invasive. The external loop recorder may effectively identify patients with new-onset AF through a validated diagnostic algorithm and targeted monitoring during a high-risk period (immediately after hospital discharge). We will prospectively randomize patients to receive an external loop recorder or standard care, evaluating rates of new-onset AF developing within 30 days after MI.
Detailed description
The SIMPL-AF trial will evaluate the role of intensive monitoring after myocardial infarction, assessing for new-onset AF after hospital discharge. Patients will be randomized to receive intensive monitoring or standard care in a 2:1 distribution. Patients randomized to intensive monitoring will receive a SpiderFlash® monitor, worn for 30-days after discharge and returned for analysis. The primary objective of this study is to evaluate at the incidence of new-onset AF at 30-days post-MI using an intensive monitoring strategy, compared to standard of care. Secondary objectives include the impact of intensive monitoring on oral anticoagulation rates at 90-days and 1-year after monitoring, and the risk factors for developing new-onset AF, and the variables associated with initiating or withholding anticoagulation.
Interventions
DIAGNOSTIC_TEST30-day ambulatory cardiac event monitor
SpiderFlash® 30-day ambulatory cardiac event monitoring will be worn upon discharge.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
2:1 enrollment into parallel groups (intensive monitoring vs. standard care).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with ST-elevation myocardial infarction (STEMI) or Non-ST-elevation myocardial infarction (NSTEMI; Third Universal Definition of MI) with or without PCI. All patients must have troponin elevation. * No history of AF during hospitalization, at discharge, or pre-existing AF documented on history (i.e. hospital records, previous hospitalization, ECG records). * No anticoagulation for AF or other indications (i.e. LV thrombus, heart valves, venous thromboembolism/deep venous thrombosis). * No concomitant disease expected to reduce expected lifespan to \<2 yrs.
Exclusion criteria
* Patients receiving CABG surgery during this hospitalization or planned cardiac surgery within the next 3 months. * Patients with spontaneous coronary artery dissection (SCAD), non-atherosclerotic coronary disease (NACAD), and Takotsubo cardiomyopathy are excluded from this study. * Patients with contraindications to anticoagulation. * Patients with a chronic skin disorder on the upper torso, or an allergy to medical tape or glue.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of new-onset AF at 30-days post-MI | 30 days | New-onset AF detected through intensive monitoring or standard care (routine assessment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of oral anticoagulation | 90 days and 1-year | Prescription of anticoagulation after intensive monitoring or standard care |
| AF-related hospitalization | 90 days and 1-year | Rates of AF-related hospitalization after intensive monitoring or standard care |
| Composite cardiovascular and hospitalization events | 90 days and 1-year | All-cause hospitalization, re-infarction, stroke, and death |
Countries
Canada
Outcome results
None listed