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

NCT02392754 | Completed

• 1 other identifier: SCREEN-AF
• Study Type: interventional
• Target: 856
• Locations: 2 countries
• Sites: 28

Brief 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.

Conditions

Atrial Fibrillation; Hypertension

Keywords

Screening; Atrial Fibrillation; ECG; Primary care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Prescription of oral anticoagulation therapy

  within 6 months from randomization

• Primary endpoint detected by ECG patch monitor

  within 6 months from randomization

• 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)

  within 6 months from randomization

• Adherence, tolerability and patient satisfaction with screening devices

  within 6 months of randomization

• Clinical outcome events

  within 6 months from randomization

Study Arms (2)

Screening

EXPERIMENTAL

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.

Device: Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)

Control

NO INTERVENTION

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

Interventions

Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP) DEVICE

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.

Also known as: ZIO XT Patch ambulatory ECG patch monitor, Watch BP-Home A blood pressure monitor

Screening

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥75 years without known atrial fibrillation or atrial flutter.
• 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).
• History of hypertension requiring antihypertensive medication.
• Written informed consent from the participant.

You may not qualify if:

• Any previously documented atrial fibrillation or atrial flutter ≥30 seconds.
• Implanted pacemaker, cardiac defibrillator, cardiac loop recorder, or deep brain stimulator.
• 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.
• Has a condition which in the opinion of the enrolling physician would not permit chronic treatment with oral anticoagulant therapy.
• Patient already taking long-term oral anticoagulant therapy.
• Known allergic reaction/intolerance to skin adhesives.

Sponsors & Collaborators

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

Study Sites (28)

Crowfoot Village Family Practice

Calgary, Alberta, T3G 0B4, Canada

Location

Smith Clinic

Camrose, Alberta, Canada

Location

Edmonton Oliver PCN

Edmonton, Alberta, T5H 3V9, Canada

Location

Peaks to Praries PCN

Olds, Alberta, T4H 1B8, Canada

Location

Henry Vlaar FP

Ayr, Ontario, N0B 1E0, Canada

Location

LMC / Manna Research

Burlington, Ontario, L7R 1E2, Canada

Location

Humber River FHT - Dixon Site

Etobicoke, Ontario, M9P, Canada

Location

Halton Hills FHT

Georgetown, Ontario, L7G 4A1, Canada

Location

Haileybury FHT

Haileybury, Ontario, P0J 1K0, Canada

Location

Hamilton Medical Clinic

Hamilton, Ontario, L8J 0B6, Canada

Location

Queen's Family Health Team

Kingston, Ontario, K7L 5E9, Canada

Location

Ken Ng FP / Total Health Management

Markham, Ontario, L3P 5T7, Canada

Location

St. Lawrence Medical Clinic

Morrisburg, Ontario, K0C 1X0, Canada

Location

SKDS Research Inc.

Newmarket, Ontario, L3Y 5G8, Canada

Location

OakMed FHT

Oakville, Ontario, L6H 7S8, Canada

Location

Mark Robertson Family Practice

Owen Sound, Ontario, N4K 4K8, Canada

Location

Garden City FHT

Saint Catherines, Ontario, L2R 1R5, Canada

Location

Michael Kopp Family Practice / N Fung & M Kopp Medicine Professional Corporation

St. Catharines, Ontario, L2N 4V5, Canada

Location

Health for All FHT

Stouffville, Ontario, L6B 0T1, Canada

Location

Port Arthur Health Centre

Thunder Bay, Ontario, P7A 4V7, Canada

Location

Keele Medical Place

Toronto, Ontario, M3M 3E5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Mount Dennis Weston Health Centre

Toronto, Ontario, M6N 4N6, Canada

Location

Sameh Fikry Medicine Professional Corporation

Waterloo, Ontario, N2J 1C4, Canada

Location

Goethe University Frankfurt am Main

Frankfurt am Main, Germany

Location

Universitätsmedizin Göttingen

Göttingen, Germany

Location

Hamburg University Medical School

Hamburg, Germany

Location

Related Publications (1)

• Gladstone DJ, Wachter R, Schmalstieg-Bahr K, Quinn FR, Hummers E, Ivers N, Marsden T, Thornton A, Djuric A, Suerbaum J, von Grunhagen D, McIntyre WF, Benz AP, Wong JA, Merali F, Henein S, Nichol C, Connolly SJ, Healey JS; SCREEN-AF Investigators and Coordinators. Screening for Atrial Fibrillation in the Older Population: A Randomized Clinical Trial. JAMA Cardiol. 2021 May 1;6(5):558-567. doi: 10.1001/jamacardio.2021.0038.

  PMID: 33625468 DERIVED

Related Links

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

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• David J. Gladstone, MD PhD FRCPC

  Sunnybrook Research Institute, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: March 19, 2015
• Study Start: April 1, 2015
• Primary Completion: October 21, 2019
• Study Completion: January 21, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

DE (3); CA (25)