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NCT03911986Completed

Risk-Based Screening for the Evaluation of Atrial Fibrillation Trial

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

Source: ClinicalTrials.gov · Last updated 28 Feb 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
755 (actual)
First submitted
21 Mar 2018
Start date
21 Mar 2018
Primary completion date
30 Jun 2023
Lead sponsor
National University of Ireland, Galway, Ireland
NCT number
NCT03911986

What you commit to

  • Study type: Interventional
  • Participants enrolled: 755
  • From 21 Mar 2018 to the primary completion date, 30 Jun 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindication to oral anticoagulant therapy
    • History of intracerebral haemorrhage
    • 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)
    • Gastrointestinal haemorrhage of unexplained or unmodifiable aetiology (i.e. risk of haemorrhage has not been reduced)
    • Other major bleed that would exclude oral anticoagulant therapy
  • Currently prescribed oral anticoagulant therapy
  • Unsuitable for anticoagulant therapy, in opinion of attending general practitioner

Other illness

  • Unsuitable for cardiac monitoring, in opinion of attending general practitioner
  • Allergies to plasters or adhesives
  • Has had cardiac monitoring for \>48 hours within the last 12 months, has an implantable loop recorder, or scheduled to have cardiac monitoring/ILR.

Other

  • Known Atrial fibrillation/flutter

Who the study is looking for

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

Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
HRB Clinical Research Facility Galway
Coordinator of this site? Confirm its status
GalwayIrelandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.