DeteCtiON and Stroke PreventIon by MoDEl ScRreenING for Atrial Fibrillation

Summary

Atrial fibrillation (AF) is the most common clinical arrhythmia and the prevalence increases with age. AF increases the risk of ischaemic stroke fivefold and accounts for almost one-third of all strokes. As AF is often asymptomatic there are many undetected cases. It is important to find patients with AF and additional risk factors for stroke in order to initiate oral anticoagulation treatment, which can reduce the risk of an ischaemic stroke by 60-70%. Screening is recommended in European guidelines, however the most suitable population and the most suitable device for AF detection remain to be defined.

The main objective of this study is to test the hypothesis that AF screening with 14-days continuous ECG monitoring in high-risk individuals identified with a risk prediction model is more effective than routine care in identifying patients with undetected AF.

Effectively detecting AF among patients with risk factors for ischaemic stroke has the potential to decrease mortality and morbidity, stroke burden and costs for the society as a whole.

Conditions

• Atrial Fibrillation
• Atrial Flutter

Interventions

DIAGNOSTIC_TEST

Risk prediction model

A risk prediction model (RPM) based on logistic regression. The RPM uses 13 variables accessible in healthcare registers to identify individuals with high future risk for developing AF. ICD-10 codes will be used.

DIAGNOSTIC_TEST

14-days continuous ECG monitoring

14-days continuous ECG monitoring with an ECG patch.

Sponsors & Collaborators

• Bristol-Myers Squibb

  lead INDUSTRY

• Region Halland

  collaborator OTHER

• Halmstad University

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Pfizer

  collaborator INDUSTRY

• Philips Healthcare

  collaborator INDUSTRY

Principal Investigators

• Johan Engdahl, MD, PhD · Karolinska Institutet

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-04

Primary Completion

2024-05-16

Completion

2024-05-16

Countries

• Sweden

Study Locations