Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older

Hypertension Clinical Trial

— SCREEN-AF  

Official title:

Program for Identification of "Actionable" Atrial Fibrillation (PIAAF): Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older: the SCREEN-AF Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392754
• Other study ID #: SCREEN-AF
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: January 21, 2020

Study information

• Verified date: January 2020
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Atrial fibrillation (AF) is a major treatable risk factor for stroke, but it may be hard to detect because it is frequently silent and intermittent. New ambulatory cardiac monitoring technologies have the potential to improve early detection of AF. This trial investigates AF screening in primary care patients using the ZIO XT Patch, a wearable adhesive patch monitor that provides continuous ECG recording for up to 14 days, in addition to the WatchBP home blood pressure monitor that has built-in AF screening capability.

Description:

SCREEN-AF is an investigator-initiated, multicenter, open-label, two-group randomized controlled trial investigating non-invasive, home-based AF screening. The trial targets patients aged 75 years or older with a history of hypertension and without known AF who would be potential anticoagulant candidates if AF were detected. Eligible participants will be recruited from primary care practices and randomly allocated (1:1) to one of two groups:

• The control group will receive standard care for 6 months (including a pulse check and heart auscultation by a physician at baseline and 6 months).

• The intervention group will undergo ambulatory screening for AF with a 2-week continuous ECG patch monitor worn at baseline and again at 3 months, in addition to standard care for 6 months (including a pulse check and heart auscultation by a physician at baseline and 6 months). The intervention group will also receive a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring blocks.

The hypothesis is that continuous ambulatory cardiac rhythm monitoring using an adhesive ECG patch monitor will be superior to standard care for AF detection. The overall aim of this research is to establish a practical and cost-effective screening strategy that could be applied in primary care for early detection of AF in patients who would benefit from anticoagulant therapy if AF were detected. The ultimate goal of this primary prevention initiative is to prevent more strokes, and stroke-related deaths, disability, dementia, hospitalizations and institutionalization, through the early detection and treatment of AF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 856
• Est. completion date: January 21, 2020
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

1. Age =75 years without known atrial fibrillation or atrial flutter.

2. The participant is clinically in sinus rhythm (both heart auscultation and 30- second pulse palpation have been performed by the enrolling physician and neither detects an irregular rhythm suggestive of atrial fibrillation).

3. History of hypertension requiring antihypertensive medication.

4. Written informed consent from the participant.

Exclusion Criteria:

1. Any previously documented atrial fibrillation or atrial flutter =30 seconds.

2. Implanted pacemaker, cardiac defibrillator, cardiac loop recorder, or deep brain stimulator.

3. Likely to be poorly compliant or unreliable using home screening devices or with study follow-up requirements because of cognitive or other issues, or life expectancy <6 months due to concomitant disease.

4. Has a condition which in the opinion of the enrolling physician would not permit chronic treatment with oral anticoagulant therapy.

5. Patient already taking long-term oral anticoagulant therapy.

6. Known allergic reaction/intolerance to skin adhesives.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hypertension

Intervention

Device:
• Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)
The intervention group receives AF screening with a 2-week ambulatory ECG patch monitor (ZIO XT Patch) worn at baseline and again at 3 months, in addition to standard care for 6 months. The intervention group also receives a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring periods.

Locations

Country	Name	City	State
Canada	Henry Vlaar FP	Ayr	Ontario
Canada	LMC / Manna Research	Burlington	Ontario
Canada	Crowfoot Village Family Practice	Calgary	Alberta
Canada	Smith Clinic	Camrose	Alberta
Canada	Edmonton Oliver PCN	Edmonton	Alberta
Canada	Humber River FHT - Dixon Site	Etobicoke	Ontario
Canada	Halton Hills FHT	Georgetown	Ontario
Canada	Haileybury FHT	Haileybury	Ontario
Canada	Hamilton Medical Clinic	Hamilton	Ontario
Canada	Queen's Family Health Team	Kingston	Ontario
Canada	Ken Ng FP / Total Health Management	Markham	Ontario
Canada	St. Lawrence Medical Clinic	Morrisburg	Ontario
Canada	SKDS Research Inc.	Newmarket	Ontario
Canada	OakMed FHT	Oakville	Ontario
Canada	Peaks to Praries PCN	Olds	Alberta
Canada	Mark Robertson Family Practice	Owen Sound	Ontario
Canada	Michael Kopp Family Practice / N Fung & M Kopp Medicine Professional Corporation	St. Catharines	Ontario
Canada	Garden City FHT	St. Catherines	Ontario
Canada	Health for All FHT	Stouffville	Ontario
Canada	Port Arthur Health Centre	Thunder Bay	Ontario
Canada	Keele Medical Place	Toronto	Ontario
Canada	Mount Dennis Weston Health Centre	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario
Canada	Sameh Fikry Medicine Professional Corporation	Waterloo	Ontario
Germany	Goethe University Frankfurt am Main	Frankfurt am Main
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Hamburg University Medical School	Hamburg

Sponsors (9)

Lead Sponsor	Collaborator
Population Health Research Institute	Canadian Institutes of Health Research (CIHR), Canadian Stroke Network, Canadian Stroke Prevention Intervention Network, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Heart and Stroke Foundation of Canada, iRhythm Technologies, Inc., Microlife, University of Leipzig

Countries where clinical trial is conducted

Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of new atrial fibrillation or flutter	Detection of new AF (atrial fibrillation or atrial flutter) within 6 months post-randomization, with AF defined as at least one episode of continuous AF lasting >5 minutes or AF documented on at least one 12-lead ECG or a convincing clinical diagnosis of AF based on reliable source documentation.	within 6 month from randomization
Secondary	Prescription of oral anticoagulation therapy	Oral anticoagulant therapy use at 3 and 6 months post-randomization.	within 6 months from randomization
Secondary	Primary endpoint detected by ECG patch monitor	Among intervention group patients that meet the primary endpoint, detected by the ECG patch monitor, the following criteria will be analyzed: time to first detection of AF >5 minutes; daily and total AF burden; average duration per AF episode.	within 6 months from randomization
Secondary	Atrial fibrillation episodes of various durations (detection of any AF episode =30 seconds, =30 seconds to 5 minutes, >5 hours, and >24 hours (to facilitate comparison with other studies in the literature)	Among intervention group patients, detection of any AF episode =30 seconds, =30 seconds to 5 minutes, >5 hours, and >24 hours (to facilitate comparison with other studies in the literature).	within 6 months from randomization
Secondary	Adherence, tolerability and patient satisfaction with screening devices	This is a composite outcome measured by the following: Patient adherence with the screening devices (defined as the average number of monitoring days completed and reasons for non-adherence); Patient satisfaction with the screening devices (as measured by user satisfaction surveys), - Tolerability of the ECG monitor (defined as the incidence of adverse skin reactions related to the adhesive patch).	within 6 months of randomization
Secondary	Clinical outcome events	A clinical outcome event will be defined as one of the following: ischemic stroke; TIA; systemic embolism; major bleeding; intracranial hemorrhage; physician visits; hospitalizations; medication prescriptions. Clinical outcome events will be captured within 6 months post-randomization. The outcome is a composite measure.	within 6 months from randomization
Secondary	Cost effectiveness of screening	The cost effectiveness of screening is a composite outcome. The outcome will be measured by cost-effectiveness (cost per life year saved) and cost-utility (cost per quality adjusted life year (QALY) gained) of AF screening.	within 6 months from randomization
Secondary	Detection of other (non-AF) clinically important arrhythmias	Detection of other potentially clinically important non-AF arrhythmias: atrial tachycardia, pause >3 seconds, high-grade atrioventricular block (Mobitz type II or third-degree AV block), ventricular tachycardia, polymorphic ventricular tachycardia/ventricular fibrillation.	within 6 months from randomization
Secondary	Sensitivity and specificity of Watch BP Home-A monitor ( false positive rate of a home AF-BP monitor (with ECG patch monitor as the gold standard).	Estimated sensitivity, specificity and false positive rate of a home AF-BP monitor (with ECG patch monitor as the gold standard).	within 6 months from randomization

External Links

•   This website explains the SCREEN AF study and the C-SPIN network