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

Primary Purpose

Paroxysmal Atrial Fibrillation, Stroke

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Automated Cardiac Event Recorder
Personal Heart Rhythm Monitor
Sponsored by
University of Surrey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Paroxysmal Atrial Fibrillation focused on measuring Cardiac monitoring, Biomarkers, Transthoracic echocardiography

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Royal Surrey County Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Personal Heart Rhythm Monitor

Arm Description

Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
The sensitivity and specificity of serum biomarkers to detect cases of PAF.
The sensitivity and specificity of markers of left atrial function to predict PAF.
The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period.
Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals.
Stroke reduction in the local area
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.
Referrals to secondary care for suspected AF/palpitations
The number of referrals to secondary care for suspected PAF will be analysed.
Participant satisfaction with the devices used in the study.

Full Information

First Posted
May 29, 2013
Last Updated
April 24, 2017
Sponsor
University of Surrey
Collaborators
Royal Surrey County Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01867060
Brief Title
Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Surrey
Collaborators
Royal Surrey County Hospital NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Stroke
Keywords
Cardiac monitoring, Biomarkers, Transthoracic echocardiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personal Heart Rhythm Monitor
Arm Type
Other
Arm Description
Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor.
Intervention Type
Device
Intervention Name(s)
Automated Cardiac Event Recorder
Other Intervention Name(s)
'R. Test Evolution 4' (Novacor).
Intervention Description
Automated Cardiac Event Recorder to be worn continuously for one week.
Intervention Type
Device
Intervention Name(s)
Personal Heart Rhythm Monitor
Other Intervention Name(s)
'Portable ECG monitor HCG-801' (OMRON Healthcare).
Intervention Description
Personal Heart Rhythm Monitor to be used twice-daily for three months.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
The sensitivity and specificity of serum biomarkers to detect cases of PAF.
Time Frame
18 months
Title
The sensitivity and specificity of markers of left atrial function to predict PAF.
Time Frame
18 months
Title
The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period.
Time Frame
18 months
Title
Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals.
Time Frame
30 months
Title
Stroke reduction in the local area
Description
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.
Time Frame
30 months
Title
Referrals to secondary care for suspected AF/palpitations
Description
The number of referrals to secondary care for suspected PAF will be analysed.
Time Frame
18 months
Title
Participant satisfaction with the devices used in the study.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippa Howlett, MBChB BSc
Organizational Affiliation
The Royal Surrey County Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward Leatham, MBChB MD
Organizational Affiliation
The Royal Surrey County Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chris Fry, BSc PhD
Organizational Affiliation
The University of Surrey
Official's Role
Study Director
Facility Information:
Facility Name
Royal Surrey County Hospital NHS Foundation Trust
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.haste.uk.com
Description
HASTE charity website

Learn more about this trial

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

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