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Stroke, CardiovascularHUA-TUONCT04523649

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

A study testing Remote atrial fibrillation screening with handheld single lead ECG recorder in people with Stroke, Cardiovascular, run by The University of Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Cardiovascular
What is being tested?
Remote atrial fibrillation screening with handheld single lead ECG recorder
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,740 participants
Where
No sites listed yet
Study dates
1 Jun 2022to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Chung-Wah David SIU, Prof contact

+852-2255-4694

cwdsiu@hku.hk

About this study

Official title: 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.

Read the 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.

Being tested
Remote atrial fibrillation screening with handheld single lead ECG recorder
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote atrial fibrillation screening with handheld single lead ECG recorderDevice

    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.

Study groups in NCT04523649
Study groupRoleWhat they receive
Home-based atrial fibrillation screening groupExperimentalPatients 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.
Receives: Device: Remote atrial fibrillation screening with handheld single lead ECG recorder
Control groupNo interventionConventional medical care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (6)

  1. Recurrent stroke

    Existence of subsequent stroke after joining the study

    Measured: 2 years

  2. Transient ischemic attack (TIA)

    Existence of subsequent TIA after joining the study

    Measured: 2 years

  3. Initiation of long-term anticoagulation therapy

    Initiation of long-term anticoagulation therapy after joining the study for any medical purposes

    Measured: 2 years

  4. Hospitalization of heart failure

    First hospitalization of heart failure after joining the study

    Measured: 2 years

  5. Cardiovascular death

    Death due to cardiovascular reasons after joining the study

    Measured: 2 years

  6. All-cause death

    Death due to all causes after joining the study

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2020
  2. Study start1 Jun 2022 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, multi-centered, randomized controlled, parallel-group study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,740 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04523649
Sponsor's protocol ID
HUA-TUO
Acronym
HUA-TUO
Status last verified
Feb 2022
First submitted
19 Aug 2020
Last updated
15 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Dataset used during the study will be available from the corresponding author on reasonable request from date of publication for 2 years.

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.

    PubMed 35840293

Questions about this trial

What is this clinical trial studying?

A study testing Remote atrial fibrillation screening with handheld single lead ECG recorder in people with Stroke, Cardiovascular, run by The University of Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chung-Wah David SIU, Prof (+852-2255-4694, cwdsiu@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First detection of AF (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04523649, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.

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