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

NCT04523649 | Unknown DMC

• 1 other identifier: HUA-TUO
• Study Type: interventional
• Target: 1,740
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• First detection of AF

  First detection of AF by the handheld ECG, defined as an episode of irregular heart rhythm, without detectable P waves, lasting more than 30 seconds

  2 years

Secondary Outcomes (6)

• Recurrent stroke

  2 years

• Transient ischemic attack (TIA)

  2 years

• Initiation of long-term anticoagulation therapy

  2 years

• Hospitalization of heart failure

  2 years

• Cardiovascular death

  2 years

Study Arms (2)

Home-based atrial fibrillation screening group

EXPERIMENTAL

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.

Device: Remote atrial fibrillation screening with handheld single lead ECG recorder

Control group

NO INTERVENTION

Conventional medical care

Interventions

Remote atrial fibrillation screening with handheld single lead ECG recorder DEVICE

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.

Home-based atrial fibrillation screening group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>= 18 years
• history of ischemic stroke within 5 years
• voluntarily agrees to participate by providing written informed consent

You may not qualify if:

• previously documented AF and/or atrial flutter
• long-term anticoagulation therapy
• short life expectance (\< 1year) due to concomitant medical condition(s)
• cardiac implantable electronic device
• inability or refusal to provide inform consent
• lack of skills in operating simple electronic devices
• unavailability of a mobile network service in the place of residence

Sponsors & Collaborators

• The University of Hong Kong: lead

Related Publications (1)

• Wong CK, Hai JJ, Lau YM, Zhou M, Lui HW, Lau KK, Chan KH, Mok TM, Liu Y, Feng Y, Tan N, Tam WC, Tam KC, Feng X, Zuo ML, Yin LX, Tan J, Zhang WJ, Jiang X, Huang X, Ye J, Liang Y, Jiang W, Lei Z, Huang D, Yue WS, Tan G, Yan BP, Evora MA, Chen JY, Siu CW. Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial. BMJ Open. 2022 Jul 15;12(7):e053466. doi: 10.1136/bmjopen-2021-053466.

  PMID: 35840293 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Chung-Wah David Siu, Prof

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung-Wah David SIU, Prof

CONTACT

+852-2255-4694; cwdsiu@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent research officers and data staff responsible for data entry will be blinded from randomization assignment.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multi-centered, randomized controlled, parallel-group study

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: June 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Dataset used during the study will be available from the corresponding author on reasonable request from date of publication for 2 years.
• Access Criteria: Dataset used during the study will be available from the corresponding author on reasonable request from date of publication for 2 years.