Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04523649 |
| Other study ID # |
HUA-TUO |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2022 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
February 2022 |
| Source |
The University of Hong Kong |
| Contact |
Chung-Wah David SIU, Prof |
| Phone |
+852-2255-4694 |
| Email |
cwdsiu[@]hku.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
