Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation (SIMPL-AF)

University of British Columbia

Status: Active, not recruiting

Conditions: Atrial Fibrillation New Onset; Myocardial Infarction

Treatments: Diagnostic Test: 30-day ambulatory cardiac event monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT03345615

H17-01060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Intensive Monitoring

Experimental group

Description:

30-day ambulatory cardiac event monitoir

Treatment:

Diagnostic Test: 30-day ambulatory cardiac event monitor

Standard Care

No Intervention group

Description:

Standard Care (no supplemental monitoring)