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

Protocol for Rationale and Design of Home-Based SolUtion for Remote Atrial Fibrillation Screening to PrevenT RecUrrence StrOke (HUA-TUO AF Trial): A Randomized Open-label Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke, Cardiovascular
• Intervention / Treatment: Device: Remote atrial fibrillation screening with handheld single lead ECG recorder

Detailed Description

The trial will primarily be conducted in Hong Kong SAR, Macau SAR, and mainland China. It is a prospective, multi-centered, randomized controlled, parallel-group study to compare the time to detect AF with portable handheld single lead ECG recorder versus conventional care in patients with history of ischemic stroke without documented AF. Patients will be randomly assigned in a 1:1 ratio to Home-based AF screening group and Control group.

The home-based AF screening system comprises (1) a handheld single lead electrocardiogram (ECG) recorder (Comfit Healthcare Devices Limited, Hong Kong SAR, China), and (2) a patient-facing smartphone application specially designed for the study. Patients randomized to the home-based AF group will be instructed to record a 30-second single lead ECG using the handheld ECG device every morning or when symptomatic. In addition, all study participants will be instructed to measure and report their blood pressures in the morning and evening through the patient-facing smartphone application. In addition, all study participants will be encouraged to input their routine blood tests from the public hospitals through the smartphone application.

All remotely obtained data will be automatically transmitted in real-time through the study smartphone application to a secured cloud hosting and displayed to display on a web-based dashboard at the clinicians' offices for review. All ECG recordings will be analyzed using an artificial intelligence based diagnosed system. When a diagnosis of AF is made with the system, the patients will be called back for a formal cardiology consultation and standard 12-lead ECG to confirm the diagnosis within 1 week. This will be followed by echocardiogram and blood tests to determine the possible options of long-term anticoagulation therapy.

• Study Type: Interventional
• Enrollment (Anticipated): 1740
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chung-Wah David SIU, Prof; Phone Number: +852-2255-4694; Email: cwdsiu@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based atrial fibrillation screening group; 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; 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.
No Intervention: Control group; Conventional medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent stroke	Existence of subsequent stroke after joining the study	2 years
Transient ischemic attack (TIA)	Existence of subsequent TIA after joining the study	2 years
Initiation of long-term anticoagulation therapy	Initiation of long-term anticoagulation therapy after joining the study for any medical purposes	2 years
Hospitalization of heart failure	First hospitalization of heart failure after joining the study	2 years
Cardiovascular death	Death due to cardiovascular reasons after joining the study	2 years
All-cause death	Death due to all causes after joining the study	2 years

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Chung-Wah David Siu, Prof, The University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: February 27, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Arrhythmias, Cardiac; Infarction; Myocardial Infarction; Stroke; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: HUA-TUO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Dataset used during the study will be available from the corresponding author on reasonable request from date of publication for 2 years.
• IPD Sharing Time Frame: Dataset used during the study will be available from the corresponding author on reasonable request from date of publication for 2 years.
• IPD Sharing Access Criteria: Dataset used during the study will be available from the corresponding author on reasonable request from date of publication for 2 years.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No