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| Name | Class |
|---|---|
| Canadian Stroke Prevention Intervention Network | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Heart and Stroke Foundation of Canada | OTHER |
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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.
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 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prescription of oral anticoagulation therapy | Oral anticoagulant therapy use at 3 and 6 months post-randomization. | within 6 months from randomization |
| Primary endpoint detected by ECG patch monitor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J. Gladstone, MD PhD FRCPC | Sunnybrook Research Institute, University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crowfoot Village Family Practice | Calgary | Alberta | T3G 0B4 | Canada | ||
| Smith Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33625468 | Derived | 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. |
| Label | URL |
|---|---|
| This website explains the SCREEN AF study and the C-SPIN network | View source |
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| Canadian Stroke Network |
| OTHER |
| iRhythm Technologies, Inc. | INDUSTRY |
| Microlife | INDUSTRY |
| University of Leipzig | OTHER |
| Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) | OTHER |
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Among intervention group patients that meet the primary endpoint, detected by the ECG patch monitor, the following criteria will be analyzed:
| 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) | 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 |
| Adherence, tolerability and patient satisfaction with screening devices | This is a composite outcome measured by the following:
| within 6 months of randomization |
| Clinical outcome events | A clinical outcome event will be defined as one of the following:
| within 6 months from randomization |
| 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 |
| 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 |
| 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 |
| Camrose |
| Alberta |
| Canada |
| Edmonton Oliver PCN | Edmonton | Alberta | T5H 3V9 | Canada |
| Peaks to Praries PCN | Olds | Alberta | T4H 1B8 | Canada |
| Henry Vlaar FP | Ayr | Ontario | N0B 1E0 | Canada |
| LMC / Manna Research | Burlington | Ontario | L7R 1E2 | Canada |
| Humber River FHT - Dixon Site | Etobicoke | Ontario | M9P | Canada |
| Halton Hills FHT | Georgetown | Ontario | L7G 4A1 | Canada |
| Haileybury FHT | Haileybury | Ontario | P0J 1K0 | Canada |
| Hamilton Medical Clinic | Hamilton | Ontario | L8J 0B6 | Canada |
| Queen's Family Health Team | Kingston | Ontario | K7L 5E9 | Canada |
| Ken Ng FP / Total Health Management | Markham | Ontario | L3P 5T7 | Canada |
| St. Lawrence Medical Clinic | Morrisburg | Ontario | K0C 1X0 | Canada |
| SKDS Research Inc. | Newmarket | Ontario | L3Y 5G8 | Canada |
| OakMed FHT | Oakville | Ontario | L6H 7S8 | Canada |
| Mark Robertson Family Practice | Owen Sound | Ontario | N4K 4K8 | Canada |
| Garden City FHT | Saint Catherines | Ontario | L2R 1R5 | Canada |
| Michael Kopp Family Practice / N Fung & M Kopp Medicine Professional Corporation | St. Catharines | Ontario | L2N 4V5 | Canada |
| Health for All FHT | Stouffville | Ontario | L6B 0T1 | Canada |
| Port Arthur Health Centre | Thunder Bay | Ontario | P7A 4V7 | Canada |
| Keele Medical Place | Toronto | Ontario | M3M 3E5 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Women's College Hospital | Toronto | Ontario | M5S 1B2 | Canada |
| Mount Dennis Weston Health Centre | Toronto | Ontario | M6N 4N6 | Canada |
| Sameh Fikry Medicine Professional Corporation | Waterloo | Ontario | N2J 1C4 | Canada |
| Goethe University Frankfurt am Main | Frankfurt am Main | Germany |
| Universitätsmedizin Göttingen | Göttingen | Germany |
| Hamburg University Medical School | Hamburg | Germany |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
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