Randomised, siteless study to compare systematic atrial fibrillation screening using enrichment by a risk prediction model with standard care in a Swedish population aged ≥ 65 years: CONSIDERING-AF study design
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Le résumé fourni par la source
INTRODUCTION: Atrial fibrillation (AF) is the most common arrhythmia and confers an increased risk of mortality, stroke, heart failure and cognitive decline. There is growing interest in AF screening; however, the most suitable population and device for AF detection remains to be elucidated. Here, we present the design of the CONSIDERING-AF (deteCtiON and Stroke preventIon by moDEl scRreenING for Atrial Fibrillation) study. METHODS AND ANALYSIS: CONSIDERING-AF is a randomised, controlled, siteless, non-blinded diagnostic superiority trial with four parallel groups and a primary endpoint of identifying AF during a 6-month study period set in Region Halland, Sweden. In each group, 740 individuals aged≥65 years will be included. The primary objective is to compare the intervention of AF screening enrichment using a risk prediction model (RPM), followed by 14 days of a continuous ECG patch, with no intervention (standard care). Primary outcome is defined as the incident AF recorded in the Region Halland Information Database after 6 months as compared with standard care. Secondary endpoints include the difference in incident AF between groups enriched or not by the RPM, with and without an invitation to 14 days of continuous ECG recording, and the proportions of oral anticoagulation treatment in the four groups. ETHICS AND DISSEMINATION: This study has ethical approval from the Swedish Ethical Review Authority. Results will be published in peer-reviewed international journals. TRIAL REGISTRATION NUMBER: NCT05838781.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Randomised, siteless study to compare systematic atrial fibrillation screening using enrichment by a risk prediction model with standard care in a Swedish population aged ≥ 65 years: CONSIDERING-AF study design
- Date Crossref
- 01/01/2024
- Éditeur
- BMJ
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Region Halland pays non établi dans la noticeOrganisme public
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Halmstad University Center for Applied Intelligent Systems Research in Health (CAISR Health) pays non établi dans la noticeUniversité ou école supérieure
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Varberg Hospital pays non établi dans la noticeÉtablissement de santé
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Pfizer (Sweden) pays non établi dans la noticeEntreprise
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Bristol-Myers Squibb (Sweden) pays non établi dans la noticeEntreprise
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Ambulatory Monitoring (United States) pays non établi dans la noticeEntreprise
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Philips (United States) pays non établi dans la noticeEntreprise
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Karolinska Institutet pays non établi dans la noticeUniversité ou école supérieure
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Department of Research and Development (FoU) pays non établi dans la noticeInstitution
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Department of Medicine pays non établi dans la noticeInstitution
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Pfizer AB pays non établi dans la noticeInstitution
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Bristol Myers Squibb AB pays non établi dans la noticeInstitution
Region Halland, Center for Applied Intelligent Systems Research in Health (CAISR Health) — Halmstad University et Varberg Hospital, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.