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Trial record 5 of 14 for:    Atrial Fibrillation, Familial, 12

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

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ClinicalTrials.gov Identifier: NCT02392754
Recruitment Status : Recruiting
First Posted : March 19, 2015
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Canadian Stroke Prevention Intervention Network
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Canadian Stroke Network
iRhythm Technologies, Inc.
Microlife
University of Leipzig
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Population Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Hypertension Device: Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP) Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 822 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Actual Study Start Date : April 1, 2015
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Screening
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)
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.
Other Names:
  • ZIO XT Patch ambulatory ECG patch monitor
  • Watch BP-Home A blood pressure monitor

No Intervention: Control
The control group receives standard care for 6 months (including a pulse check and heart auscultation by a physician at 6 months).



Primary Outcome Measures :
  1. New diagnosis of ECG-confirmed atrial fibrillation or flutter [ Time Frame: within 6 month from randomization ]
    New diagnosis of ECG-confirmed atrial fibrillation or flutter within 6 months postrandomization, defined as at least one episode of continuous AF >5 minutes (or AF documented on 2 separate 12-lead ECGs >5 minutes apart).


Secondary Outcome Measures :
  1. Prescription of oral anticoagulation therapy [ Time Frame: within 6 months from randomization ]
    Oral anticoagulant therapy use at 3 and 6 months post-randomization.

  2. Primary endpoint detected by ECG patch monitor [ Time Frame: within 6 months from randomization ]

    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.

  3. 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) [ Time Frame: within 6 months from randomization ]
    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).

  4. Adherence, tolerability and patient satisfaction with screening devices [ Time Frame: within 6 months of randomization ]

    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).

  5. Clinical outcome events [ Time Frame: within 6 months from randomization ]

    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.

  6. Cost effectiveness of screening [ Time Frame: within 6 months from randomization ]
    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.

  7. Detection of other (non-AF) clinically important arrhythmias [ Time Frame: within 6 months from randomization ]
    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.

  8. 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). [ Time Frame: within 6 months from randomization ]
    Estimated sensitivity, specificity and false positive rate of a home AF-BP monitor (with ECG patch monitor as the gold standard).



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392754


Contacts
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Contact: Andrea Thornton 905-527-4322 ext 40473 screen-af@phri.ca

Locations
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Canada, Alberta
Crowfoot Village Family Practice Completed
Calgary, Alberta, Canada, T3G 0B4
Smith Clinic Completed
Camrose, Alberta, Canada
Edmonton Oliver PCN Completed
Edmonton, Alberta, Canada, T5H 3V9
Peaks to Praries PCN Completed
Olds, Alberta, Canada, T4H 1B8
Canada, Ontario
Henry Vlaar FP Completed
Ayr, Ontario, Canada, N0B 1E0
LMC / Manna Research Completed
Burlington, Ontario, Canada, L7R 1E2
Humber River FHT - Dixon Site Completed
Etobicoke, Ontario, Canada, M9P
Halton Hills FHT Completed
Georgetown, Ontario, Canada, L7G 4A1
Haileybury FHT Completed
Haileybury, Ontario, Canada, P0J 1K0
Hamilton Medical Clinic Completed
Hamilton, Ontario, Canada, L8J 0B6
Queen's Family Health Team Completed
Kingston, Ontario, Canada, K7L 5E9
Ken Ng FP / Total Health Management Completed
Markham, Ontario, Canada, L3P 5T7
St. Lawrence Medical Clinic Completed
Morrisburg, Ontario, Canada, K0C 1X0
SKDS Research Inc. Completed
Newmarket, Ontario, Canada, L3Y 5G8
OakMed FHT Completed
Oakville, Ontario, Canada, L6H 7S8
Mark Robertson Family Practice Completed
Owen Sound, Ontario, Canada, N4K 4K8
Michael Kopp Family Practice / N Fung & M Kopp Medicine Professional Corporation Completed
St. Catharines, Ontario, Canada, L2N 4V5
Garden City FHT Completed
St. Catherines, Ontario, Canada, L2R 1R5
Health for All FHT Completed
Stouffville, Ontario, Canada, L6B 0T1
Thornbury Medical - Tim Remillard FP Withdrawn
Thornbury, Ontario, Canada, N0H 2P0
Port Arthur Health Centre Completed
Thunder Bay, Ontario, Canada, P7A 4V7
Keele Medical Place Completed
Toronto, Ontario, Canada, M3M 3E5
Sunnybrook Health Sciences Centre Completed
Toronto, Ontario, Canada, M4N 3M5
Women's College Hospital Completed
Toronto, Ontario, Canada, M5S 1B2
Mount Dennis Weston Health Centre Completed
Toronto, Ontario, Canada, M6N 4N6
Sameh Fikry Medicine Professional Corporation Completed
Waterloo, Ontario, Canada, N2J 1C4
Germany
Goethe University Frankfurt am Main Not yet recruiting
Frankfurt am Main, Germany
Contact: Chritiane Muth, MD         
Universitätsmedizin Göttingen Recruiting
Göttingen, Germany
Contact: Eva Hummers-Pradier, MD         
Hamburg University Medical School Recruiting
Hamburg, Germany
Contact: Martin Scherer, MD         
Sponsors and Collaborators
Population Health Research Institute
Canadian Stroke Prevention Intervention Network
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Canadian Stroke Network
iRhythm Technologies, Inc.
Microlife
University of Leipzig
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators
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Principal Investigator: David J. Gladstone, MD PhD FRCPC Sunnybrook Research Institute, University of Toronto

Additional Information:
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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT02392754     History of Changes
Other Study ID Numbers: SCREEN-AF
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Keywords provided by Population Health Research Institute:
Screening
Atrial Fibrillation
ECG
Primary care

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes