Multi-centre open label randomised controlled trial of immediate 14 day ambulatory ECG monitoring versus standard care in acute unexplained syncope patients (The ASPIRED study)

Diagnosing underlying dysrhythmia in Emergency Department (ED) syncope patients is difficult.

There is evidence that diagnostic yield for detecting underlying dysrhythmia is highest when cardiac monitoring devices are applied early, ideally at the index visit including evidence from a prospective pilot study by our group.

Using an immediate medium duration ambulatory electrocardiogram (ECG) patch monitor in ED patients with unexplained syncope, a significant dysrhythmia was detected in 3 in 10 patients (with 1 in 10 being symptomatic and serious) and a diagnostic finding in 3 in 4.

This strategy has the potential to change current syncope management from low diagnostic yield Holter to higher yield ambulatory monitoring, reduce episodes of syncope, reduce risk of recurrence and its potential serious consequences, reduce hospital admissions, reduce overall health costs and increase quality of life by allowing earlier diagnosis, treatment and exclusion of clinically important dysrhythmias.

We propose a UK open prospective parallel group multicentre randomised controlled trial of an immediate 14-day ambulatory patch heart monitor versus standard care (Holter/extended ambulatory monitor as per NICE guidance) in patients presenting acutely with unexplained syncope. Our patient focussed primary endpoint will be number of episodes of syncope at one year.