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Home-Based SolUtion for Remote Atrial Fibrillation Screening to PrevenT RecUrrence StrOke (HUA-TUO AF Trial)

NCT04523649 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1740

Last updated 2022-03-15

No results posted yet for this study

Summary

Stroke remains the leading cause of mortality and morbidity worldwide. Patients surviving the first ever stroke remain at high risk of stroke recurrence. While the cause of stroke recurrence is multifactional, atrial fibrillation (AF) has been recognized as one of the most important factors for stroke recurrence. Despite the fact that AF related stroke is highly preventable with long-term oral anticoagulation therapy particularly the non-vitamin K oral anticoagulants (NOAC), the arrhythmia is often not diagnosed until stroke recurrence due to its paroxysmal and asymptomatic nature.

Diagnosing AF before stroke recurrence has been recognized as one of the most important objectives for stroke management. Strategies to detection AF in stroke survivors have been recommended including 7-day or 14-day Holter monitoring at the early post-stroke period. There's also study trial exploring the clinical application of insertable cardiac monitor to detect AF in patients with recent cryptogenic stroke.

In the past decade, advance in ECG technology has made possible to record ECG using handheld smartphone accessory devices in household setting. Together with the rapid developing artificial intelligence-based ECG diagnosis and mobile communication, it is possible to remotely monitor hundreds of thousand ECGs from patients at risk of AF. Few randomized trials have assessed the effectiveness of handheld ECG recording device for AF detection in patients with history of stroke. Here we test the hypothesis that long-term home-based ECG monitoring will be more sensitive than standard care in detecting AF in patients with history of stroke but no documented AF for 24 months. Secondarily, we will investigate whether early detection of AF might confer a benefit on longer-term clinical outcomes.

Conditions

  • Stroke, Cardiovascular

Interventions

DEVICE

Remote atrial fibrillation screening with handheld single lead ECG recorder

Patients in this group will be given a handheld single lead ECG recorder (Comfit Healthcare Devices Limited, Hong Kong SAR, China) and a patient-facing smartphone application specially designed for the study, and they will be requested to record daily ECG and certain vital measurement.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Chung-Wah David Siu, Prof · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04523649 on ClinicalTrials.gov