DeteCtiON and Stroke PreventIon by MoDEl ScRreenING for Atrial Fibrillation

NCT ID: NCT05838781

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2024-05-16

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.

Detailed Description

Objective(s): To compare the yield of atrial fibrillation (AF) using 14-days continuous ECG in a population aged ≥ 65 years with an increased risk for AF incidence according to the risk prediction model compared with standard of care in Region Halland.

Study Population: Residents in Region Halland age 65 and above.

Data Collection Methods: Electronic Health Records from Region Halland and 14-days continuous ECG recording using an ECG patch.

Study design:

Step 1:

To calibrate the BMS/Pfizer risk prediction model (RPM), we will extract two cohorts retrospectively: the AF cohort with an AF diagnosis (patients with a record of incident AF diagnosis between January 1, 2016, and December 31, 2019 as an observation period), and the control cohort without any AF diagnosis in their history. We will include patients ≥45 years of age at index date, which is the first date of an AF diagnosis recorded in the observation period and a random pseudo index date during the observation period for the control group, to follow the original study. Specifically, we are looking to calibrate the intercept (α) for the logistic regression where we already have the 13 odd ratios for the 13 risk factors from the original study. Then in the next step for the prospective study, applying the RPM on the RPM cohort, the at-risk group will be extracted for randomization step, using the recommended cut-off value.

Step 2:

The population in Region Halland aged 65 years and above and free from AF will be randomized into two halves, creating a general cohort and an RPM cohort. In the general cohort, 1480 individuals will be further randomized into two arms, general/control and general/intervention. In the RPM cohort, the risk of incident AF will be calculated according to the Pfizer/BMS RPM. Those with a predicted risk for incident AF above a pre-specified threshold will then be randomly extracted into two arms, RPM/control and RPM/intervention (figure 1).

Those randomized to the two intervention arms (general/intervention and RPM/intervention, n=740 each) will be invited to an AF screening intervention of 14-days continuous ECG using a patch device. Those randomized to the control groups (general/control and RPM/control, n=740 each) will not receive any information or intervention.

The primary endpoint will be the difference in yield of newly diagnosed AF between the RPM/intervention and the general/control arms, where the latter will represent standard of care. Participants with newly diagnosed AF in the intervention arms will be offered consultation aiming at AF work-up and initiation of oral anticoagulation treatment.

Conditions

Atrial Fibrillation; Atrial Flutter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

General/control

Standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

General/intervention

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

Group Type: EXPERIMENTAL

14-days continuous ECG monitoring

Intervention Type: DIAGNOSTIC_TEST

14-days continuous ECG monitoring with an ECG patch.

Risk prediction model/control

Standard of care.

Group Type: EXPERIMENTAL

Risk prediction model

Intervention Type: 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/intervention

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

Group Type: EXPERIMENTAL

Risk prediction model

Intervention Type: 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.

14-days continuous ECG monitoring

Intervention Type: DIAGNOSTIC_TEST

14-days continuous ECG monitoring with an ECG patch.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

14-days continuous ECG monitoring

14-days continuous ECG monitoring with an ECG patch.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Halland

OTHER

Sponsor Role: collaborator

Halmstad University

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Philips Healthcare

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Johan Engdahl, MD

Associate Professor, Senior consultant, Karolinska Institutet

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johan Engdahl, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet Danderyd University Hospital

Stockholm, Outside US, Sweden

Halland Hospital Varberg

Varberg, Outside US, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 38216189 (View on PubMed)

Other Identifiers

CV185-837

Identifier Type: -

Identifier Source: org_study_id