Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community

April 24, 2017 updated by: University of Surrey

Using a Personal Heart Rhythm Monitor (PHRM) to Diagnose Paroxsymal Atrial Fibrillation (PAF) in the Community; and the PREDICT-PAF Substudy - an Investigation of Biomarkers to Detect PAF.

This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3 months, will detect significantly more cases of PAF than the ACER, used continuously for one week.

A case-control sub-study will identify individuals with confirmed PAF, and matched individuals with no evidence of PAF, to identify potential serum biomarkers for PAF.

A further case-control study will assess markers of left atrial function in patients with PAF and their matched controls.

Another case-control sub-study will determine the significance of frequent Atrial Premature Beats (APBs) in the development of AF over a one year period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with suspected AF will be initially referred to a community-based, nurse-led Arrhythmia clinic by their General Practitioners over a 15-month period.

All patients will be issued with a one week ACER (the 'R. Test 4 Evolution'), seen as the 'best-practice' investigation for this population group. Participants will also be issued with a PHRM for three months. They will be instructed to take regular twice-daily, 30 second recordings with additional recordings in the event of relevant symptoms. They will return the ACER after one week and the PHRM after 3 months.

A subgroup of participants (target recruitment number = 100) will undergo transthoracic echocardiography. A 40ml venous blood sample will also be taken. Another small subgroup (target recruitment = 20) will be asked to continue twice-daily recordings using the PHRM for a further nine months and will be issued with a repeat one week ACER at study completion.

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Suspected paroxysmal AF (either palpitations consistent with AF or an irregular pulse)
  • 12-lead resting ECG confirming sinus rhythm
  • Capacity to consent to study
  • English-speaking
  • Life expectancy at least one year

Exclusion Criteria:

  • Previous diagnosis of AF
  • Recent history of syncope
  • Recent history of cardiac-sounding chest pain
  • A resting ECG suggestive of alternative arrhythmia
  • Inability to use the telephone
  • Thyrotoxicosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Personal Heart Rhythm Monitor
Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor.
Device: Automated Cardiac Event Recorder
Automated Cardiac Event Recorder to be worn continuously for one week.
Other Names:
  • 'R. Test Evolution 4' (Novacor).
Device: Personal Heart Rhythm Monitor
Personal Heart Rhythm Monitor to be used twice-daily for three months.
Other Names:
  • 'Portable ECG monitor HCG-801' (OMRON Healthcare).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect all episodes of paroxysmal atrial fibrillation.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect prolonged episodes of paroxysmal atrial fibrillation (defined as greater than 12 hours).
Time Frame: 18 months
18 months
The sensitivity and specificity of serum biomarkers to detect cases of PAF.
Time Frame: 18 months
18 months
The sensitivity and specificity of markers of left atrial function to predict PAF.
Time Frame: 18 months
18 months
The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period.
Time Frame: 18 months
18 months
Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals.
Time Frame: 30 months
30 months
Stroke reduction in the local area
Time Frame: 30 months
A reduction in stroke burden in the local area will be calculated from estimated stroke risk in individuals identified with AF and from a local registry.
30 months
Referrals to secondary care for suspected AF/palpitations
Time Frame: 18 months
The number of referrals to secondary care for suspected PAF will be analysed.
18 months
Participant satisfaction with the devices used in the study.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Surrey

Collaborators

Royal Surrey County Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Philippa Howlett, MBChB BSc, The Royal Surrey County Hospital
  • Study Director: Edward Leatham, MBChB MD, The Royal Surrey County Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

May 31, 2013

First Posted (ESTIMATE)

June 3, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HASTE-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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