Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation

Conditions
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Atrial Fibrillation New Onset, Myocardial Infarction

Intervention / Treatment
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* Diagnostic Test: 30-day ambulatory cardiac event monitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2:1 enrollment into parallel groups (intensive monitoring vs. standard care).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive Monitoring<br>30-day ambulatory cardiac event monitoir | Diagnostic Test: 30-day ambulatory cardiac event monitor<br>* SpiderFlash® 30-day ambulatory cardiac event monitoring will be worn upon discharge.<br>|
| No Intervention: Standard Care<br>Standard Care (no supplemental monitoring) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of new-onset AF at 30-days post-MI | New-onset AF detected through intensive monitoring or standard care (routine assessment) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of oral anticoagulation | Prescription of anticoagulation after intensive monitoring or standard care | 90 days and 1-year | 
| AF-related hospitalization | Rates of AF-related hospitalization after intensive monitoring or standard care | 90 days and 1-year | 
| Composite cardiovascular and hospitalization events | All-cause hospitalization, re-infarction, stroke, and death | 90 days and 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, myocardial infarction, intensive monitoring, oral anticoagulation, hospitalization