DeteCtiON and Stroke PreventIon by MoDEl ScRreenING for Atrial Fibrillation

NCT05838781 | Completed

• 1 other identifier: CV185-837
• Study Type: interventional
• Target: 2,112
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Atrial Fibrillation; Atrial Flutter; Mass Screening

Outcome Measures

Primary Outcomes (1)

• Incident AF

  1. Incident AF on ECG screening (intervention arms) defined as at least one episode of AF or atrial flutter with a duration of at least 30 seconds on ambulatory ECG recording. 2. Incident AF registered in the Electronic Health Record during follow-up (all four arms).

  14 days

Secondary Outcomes (3)

• Yield newly diagnosed AF: RPM/ intervention arm versus RPM/ control arm

  14 days

• Yield newly diagnosed AF: general/ intervention arm versus RPM/ control arm

  14 days

• Yield newly diagnosed AF: general/ intervention arm versus general/ control arm

  14 days

Other Outcomes (4)

• Proportion of patients starting oral anticoagulation treatment

  18 months

• Feasibility of self-application of ECG patch

  14 days

• AF yield during the first 24 and 48 hours

  48 hours

Study Arms (4)

General/control

NO INTERVENTION

Standard of care.

General/intervention

EXPERIMENTAL

Standard of care plus 14-days continuous ECG monitoring using an ECG patch.

Diagnostic Test: 14-days continuous ECG monitoring

Risk prediction model/control

EXPERIMENTAL

Standard of care.

Diagnostic Test: Risk prediction model

Risk prediction model/intervention

EXPERIMENTAL

Standard of care plus 14-days continuous ECG monitoring using an ECG patch.

Diagnostic Test: Risk prediction model; Diagnostic Test: 14-days continuous ECG monitoring

Interventions

Risk prediction model DIAGNOSTIC_TEST

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.

Risk prediction model/control; Risk prediction model/intervention

14-days continuous ECG monitoring DIAGNOSTIC_TEST

14-days continuous ECG monitoring with an ECG patch.

General/intervention; Risk prediction model/intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Alive residents in the Halland region aged 65 or older without a recorded diagnosis of AF

You may not qualify if:

• Known atrial fibrillation
• Death
• No longer resident in Region Halland
• Pacemaker, implantable cardioverter defibrillator or insertable monitor
• Dementia
• Other indication for OAC treatment (such as VTE, mechanical heart valve replacement, VTE prophylaxis post surgery, mitral stenosis, left side intracardial thrombus)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Region Halland: collaborator
• Halmstad University: collaborator
• Karolinska Institutet: collaborator
• Pfizer: collaborator
• Philips Healthcare: collaborator

Study Sites (2)

Karolinska Institutet Danderyd University Hospital

Stockholm, Outside US, 18288, Sweden

Location

Halland Hospital Varberg

Varberg, Outside US, 43281, Sweden

Location

Related Publications (1)

• Etminani F, Sandgren E, Holm J, Magnusson P, Modica A, Moberg K, Davidsson T, Stalpe L, Kiflemariam S, Younan N, Parikh P, Wadhwa M, Sundin A, Engdahl J. 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. BMJ Open. 2024 Jan 12;14(1):e080639. doi: 10.1136/bmjopen-2023-080639.

  PMID: 38216189 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

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

Study Officials

• Johan Engdahl, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Senior consultant, Karolinska Institutet

Model Details: Siteless, randomized, 2x2 factorial design, superiority trial

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: December 4, 2023
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)