Pilot Randomized Trial of Outpatient Cardiac Monitoring After Cryptogenic Stroke

Abstract

Background and Purpose— Observational studies indicate that outpatient cardiac monitoring detects previously undiagnosed atrial fibrillation (AF) in 5% to 20% of patients with recent stroke. However, it remains unknown whether the yield of monitoring exceeds that of routine clinical follow-up. Methods— In a pilot trial, we randomly assigned 40 patients with cryptogenic ischemic stroke or high-risk transient ischemic attack to wear a Cardionet mobile cardiac outpatient telemetry monitor for 21 days or to receive routine follow-up alone. After thorough investigation, we excluded patients with documented AF or other apparent stroke pathogenesis. We contacted patients and their physicians at 3 months and at 1 year to ascertain any diagnoses of AF or recurrent stroke or transient ischemic attack. Results— The baseline characteristics of our cohort broadly matched those of previous observational studies of monitoring after stroke. In the monitoring group, patients wore monitors for 64% of the assigned days, and 25% of patients were not compliant at all with monitoring. No patient in either study arm received a diagnosis of AF. Cardiac monitoring revealed AF in zero patients (0%; 95% confidence interval, 0%–17%), brief episodes of atrial tachycardia in 2 patients (10%; 95% confidence interval, 1%–32%), and nonsustained ventricular tachycardia in 2 patients (10%; 95% confidence interval, 1%–32%). Conclusions— In the first reported randomized trial of cardiac monitoring after cryptogenic stroke, the rate of AF detection was lower than expected, incidental arrhythmias were frequent, and compliance with monitoring was suboptimal. Our findings highlight the challenges of prospectively identifying stroke patients at risk for harboring paroxysmal AF and ensuring adequate compliance with cardiac monitoring. Clinical Trial Registration— URL: http://clinicaltrials.gov . Unique Identifier: NCT00715533