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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
240
SpiderFlash® 30-day ambulatory cardiac event monitoring will be worn upon discharge.
Vancouver General Hospital
Vancouver, British Columbia, Canada
Incidence of new-onset AF at 30-days post-MI
New-onset AF detected through intensive monitoring or standard care (routine assessment)
Time frame: 30 days
Rate of oral anticoagulation
Prescription of anticoagulation after intensive monitoring or standard care
Time frame: 90 days and 1-year
AF-related hospitalization
Rates of AF-related hospitalization after intensive monitoring or standard care
Time frame: 90 days and 1-year
Composite cardiovascular and hospitalization events
All-cause hospitalization, re-infarction, stroke, and death
Time frame: 90 days and 1-year
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