Risk-Based Screening for the Evaluation of Atrial Fibrillation Trial (R-BEAT)

Risk-Based Screening for the Evaluation of Atrial Fibrillation Trial (R-BEAT)

1. To determine whether a risk-based screening programme for occult paroxysmal atrial fibrillation, involving extended cardiac monitoring in adults with CHA2DS2-VASc score of 3 or greater, increases the detection of new atrial fibrillation/flutter.
2. To determine whether a risk-based screening programme for occult paroxysmal atrial fibrillation, involving extended cardiac monitoring in adults with CHA2DS2-VASc score of 3 or greater, is cost-effective.
3. To determine the sensitivity, specificity, positive predictive value and negative predictive values of self-monitoring of pulse in adults for detection of atrial fibrillation.
4. To determine the cost, cost effectiveness, and budget impact of a risk-based screening programme for occult paroxysmal atrial fibrillation, relative to a control of usual care in general practice.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation and Flutter
• Intervention / Treatment: Device: R Test 4 External Loop Recorder

Detailed Description

Stroke is a leading cause of death and disability. A first diagnosis of atrial fibrillation may occur at the time of stroke (e.g. about 45% of patients with acute stroke). Undiagnosed atrial fibrillation is therefore a major care-gap in stroke prevention.

Against this backdrop, oral anticoagulant therapy is extremely effective at reducing the risk of ischemic stroke in atrial fibrillation, associated with a two-thirds risk reduction. Therefore, a major care gap in stroke prevention is the prevalence of undetected atrial fibrillation in the community. Traditional pulse screening in all patients > 65 years detects new atrial fibrillation in about 1% of people.

The CHA2DS2-VASc score was developed and validated to risk-stratify patients with atrial fibrillation into low, intermediate and high risk of stroke. The Investigators believe that the CHA2DS2-VASc score represents an opportunity to identify patients at high risk of atrial fibrillation, but also identifies this at highest risk of stroke, and therefore those that will derive greatest benefit from anticoagulant therapy.

The advent of external-worn event loop recorders (ELRs) present a more convenient and efficient method of detecting atrial fibrillation. Loop recorders have an in-built diagnostic algorithm that identifies atrial fibrillation, and initiates recordings before and after the event-trigger. This rhythm strip is then examined and confirmed by the trial cardiac technician. The investigators will examine if using external loop recorders in patients identified as high risk will improve the detection rate of paroxysmal atrial fibrillation.

The study is a randomised controlled cross-over multi-centered clinical trial in General Practice. Ethical approval has been sought from the Galway University Hospitals research ethics committee. The investigators have also engaged with Clinical Research Patient and Public Involvement.

The investigators primary research question is whether extended cardiac rhythm monitoring (with ELR for 1 week), compared to standard care, in patients pre-identified to be at high-risk of atrial fibrillation (defined by CHA2DS2-VASc score >2) increases the detection of new atrial fibrillation resulting in introduction of oral anticoagulant therapy, that is efficient, acceptable to patients and cost-effective.

All participating general practices will require the Socrates software package. The investigators will run analyses to identify patients with a CHA2DS2-VASc of 3 or greater. The investigators will exclude all patients with known atrial fibrillation, those in whom contraindications to oral anticoagulant therapy exist, and those who are deemed unsuitable for extended monitoring.

• Study Type: Interventional
• Enrollment (Actual): 755
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • County Galway
    • Galway, County Galway, Ireland, H91 YR71
      • HRB Clinical Research Facility Galway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed a study specific Informed Consent Form
2. 55 years of age or older
3. Attending one of the participating General Practices in the R-BEAT Trial
4. Attended at least one GP appointment within the past 12 months
5. CHA2DS2-VASc Score >2

Exclusion Criteria:

1. Contraindication to oral anticoagulant therapy

   1. History of intracerebral haemorrhage

   2. Prior intolerance or refusal of oral anticoagulant therapy

      *(If intolerant or refused warfarin, may be included if considered suitable for non vitamin-K oral anticoagulant, NOAC)

   3. Gastrointestinal haemorrhage of unexplained or unmodifiable aetiology (i.e. risk of haemorrhage has not been reduced)
   4. Other major bleed that would exclude oral anticoagulant therapy
2. Known Atrial fibrillation/flutter
3. Currently prescribed oral anticoagulant therapy
4. Unsuitable for anticoagulant therapy, in opinion of attending general practitioner
5. Unsuitable for cardiac monitoring, in opinion of attending general practitioner
6. Allergies to plasters or adhesives
7. Has had cardiac monitoring for >48 hours within the last 12 months, has an implantable loop recorder, or scheduled to have cardiac monitoring/ILR.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Immediate External Loop Recorder; Participants randomized to the Immediate External Loop Recorder group will be monitored for the duration of the first week of the study using the Novacor R-Test 4.	Device: R Test 4 External Loop Recorder; The R-Test 4 is an externally worn, re-usable, battery-powered, lightweight ECG monitor, which records events triggered by cardiac arrhythmias. It is worn for 7 days. Cardiac monitoring is triggered by tachycardia or detection of irregular pulses or patient may trigger recording, if the participant experience symptoms (e.g. palpitations). The patient wears 2 chest leads (on one, the R-Test device is attached, weight 42g). The R-Test 4 is CE marked, and uses an FDA-approved algorithm for automatic detection of atrial fibrillation, and permits 5 minutes of pre-event recording and 5 minutes of post-event recording.
Other: Delayed External Loop Recorder; Participants randomized to the Delayed External Loop Recorder group will be monitored for the duration of the second week of the study using the Novacor R-Test 4.	Device: R Test 4 External Loop Recorder; The R-Test 4 is an externally worn, re-usable, battery-powered, lightweight ECG monitor, which records events triggered by cardiac arrhythmias. It is worn for 7 days. Cardiac monitoring is triggered by tachycardia or detection of irregular pulses or patient may trigger recording, if the participant experience symptoms (e.g. palpitations). The patient wears 2 chest leads (on one, the R-Test device is attached, weight 42g). The R-Test 4 is CE marked, and uses an FDA-approved algorithm for automatic detection of atrial fibrillation, and permits 5 minutes of pre-event recording and 5 minutes of post-event recording.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New detected (and centrally confirmed) cases of atrial fibrillation/flutter > 2 minutes	New detected (and centrally confirmed) cases of atrial fibrillation/flutter > 2 minutes in duration using a built in diagnostic algorithm that identifies probable atrial fibrillation. The identified instances will be reviewed by a cardiologist for confirmation of atrial fibrillation/atrial flutter	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation of oral anticoagulation	prescription	3 months

Collaborators and Investigators

• Sponsor: National University of Ireland, Galway, Ireland
• Collaborators: Health Research Board, Ireland
• Investigators: Study Chair: Colin Hardy, BSc, Project Officer and Site Management Coordinator

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2018
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 17-CRFG 17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No