Hong Kong Outpatient AF Screening Using Single-lead ECG Device

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT02409654

Collaborator

University of Sydney (Other)

500

Enrollment

Location

Arms

56.9

Actual Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Stroke is a leading cause of mortality, morbidity and rising healthcare cost worldwide. In 'real-world' practice, AF is often diagnosed too late at time of stroke and detection can be difficult because AF may be present without symptoms and intermittent in nature. Furthermore, utilization of adequate oral anticoagulation therapy (OAC) for stroke prevention is suboptimal in Hong Kong. The challenge is to identify AF prior to occurrence of stroke. The latest European guidelines recommend opportunistic screening for people >=65 years by pulse palpation followed by 12-lead ECG. However, 12-lead ECG requires a trained technician, time consuming, requires the patient to lie on an examination couch and is not readily available in most outpatient clinics in Hong Kong. A practical screening test is needed. Our study aims to evaluate the feasibility, acceptability and incremental cost of an outpatient based AFscreening program using the AliveCor device. Newly diagnosed AF patients will be randomized to routine care versus individualized stroke prevention strategy which consists of patient education, stroke and bleeding risk assessment, evidence-based OAC recommendation, patient audit and follow-up to improve OAC utilization for stroke prevention. We envisage this study will provide timely evidence to inform policy decisions concerning population-based AF-screening for AF for stroke prevention.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Other: Patient education Other: Routine care	N/A

Detailed Description

Study Design

The study consists of 2 stages. The screening study examines the feasibility of screening to identify undiagnosed AF in the elderly (>=65 years) using a validated hand-held ECG device and the impact of screening on clinical and economic outcomes at the population level. Subsequent intervention study is a randomized-controlled study comparing an individualized stroke prevention strategy with routine care to prevent stroke in screen-detected AF patients.

Stage 1: AF Screening Study

Screening will be performed in 2 Cardiology and 4 Family Medicine Specialty Out-Patient Clinics (SOPC) at a tertiary referral hospital in Hong Kong. Subjects who meet inclusion and exclusion criteria will sign informed consent for Stage 1 and 2 studies separately, prior to conducting ECG screening.

Stage 2: Randomized Study of Individualized Stroke Prevention vs. Routine Care

Intervention

Screen detected AF patients (new or known AF) from Stage 1 who are not already receiving appropriate OAC for stroke prevention who signed informed consent are randomized 1:1 to routine care or an individualized stroke prevention strategy. Participants will be randomized using block randomization method to assure both groups have the same number of subjects.

Individualized Stroke Prevention Strategy

(i) Patient education on AF and stroke risk. (ii) Assess individual risk of stroke using the CHADS2 and CHA2DS2VASc score and risk of major bleeding using the HAS-BLED score (iii)

Recommendation of evidence-based stroke prevention therapy (iv) Patient audit and follow-up:

Patients not on appropriate OAC without adequate explanation will be referred to Cardiology SOPC for second opinion.

Routine Care

The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.

Follow-up

Participants will be followed prospectively every 12 months up to 3 years for clinical events including death, ischemic stroke, any thromboembolic events, intracranial and other major bleeding and stroke prevention therapy. Screen-detected AF patients from Stage 1 who declined to participate in the intervention study will be followed up in a registry.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

Randomized Controlled Trial of Tailored Stroke Prevention Strategy for Newly Diagnosed Atrial Fibrillation From a Targeted Screening Program Using Handheld Single-lead ECG Device

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Individualized stroke prevention (i) Patient education (ii) Assess individual risk of stroke using the CHADS2 and CHA2DS2VASc score and risk of major bleeding using the HAS-BLED score (iii) Recommendation of evidence-based stroke prevention therapy based on international guidelines (iv) Patient audit and follow-up (v) Patients not on appropriate OAC without adequate explanation will be referred to Cardiology Outpatient Clinic for second opinion	Other: Patient education (i) Patient education (ii) Assess individual risk of stroke using the CHADS2 and CHA2DS2VASc score and risk of major bleeding using the HAS-BLED score (iii) Recommendation of evidence-based stroke prevention therapy based on international guidelines (iv) Patient audit and follow-up (v) Patients not on appropriate OAC without adequate explanation will be referred to Cardiology Outpatient Clinic for second opinion Other: Routine care The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.
Placebo Comparator: Routine Care The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.	Other: Routine care The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.

Arm

Intervention/Treatment

Active Comparator: Individualized stroke prevention

(i) Patient education (ii) Assess individual risk of stroke using the CHADS2 and CHA2DS2VASc score and risk of major bleeding using the HAS-BLED score (iii) Recommendation of evidence-based stroke prevention therapy based on international guidelines (iv) Patient audit and follow-up (v) Patients not on appropriate OAC without adequate explanation will be referred to Cardiology Outpatient Clinic for second opinion

Other: Patient education

Other: Routine care

The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.

Placebo Comparator: Routine Care

The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.

Other: Routine care

The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.

Outcome Measures

Primary Outcome Measures

Utilization rates of evidence-based stroke prevention therapy [3 years]

Secondary Outcome Measures

Rates of newly diagnosed atrial fibrillation in elderly >65 years of age [3 years]
Clinical outcomes including death, stroke and bleeding [12 months]
Patient awareness questionnaire [12 months]
Incremental cost per new AF case detected [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged 65 years or over

Exclusion Criteria:

Severe coexisting medical condition that would prevent participation (eg, dementia, terminal illness)
Inability to read/understand the consent form and participation information statement

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prince of Wales Hospital	Shatin	New Territories	Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong
University of Sydney

Investigators

Principal Investigator: Bryan P Yan, MBBS, FACC, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Professor Bryan Ping Yen YAN, Associate Professor, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT02409654

Other Study ID Numbers:

HK-OPD-AF

First Posted:

Apr 7, 2015

Last Update Posted:

Oct 19, 2021

Last Verified:

Oct 1, 2021

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Oct 19, 2021