NCT03345615

Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation New Onset
• Myocardial Infarction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	30-day ambulatory cardiac event monitor	SpiderFlash® 30-day ambulatory cardiac event monitoring will be worn upon discharge.

Timeline

• Start date: 2017-11-01
• Primary completion: 2022-03-01
• Completion: 2022-12-01
• First posted: 2017-11-17
• Last updated: 2022-08-16

Locations

1 site across 1 country: Canada