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

Stroke Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867060
• Other study ID #: HASTE-2
• Status: Completed
• Phase: Phase 3
• First received: May 29, 2013
• Last updated: April 24, 2017
• Start date: May 2013
• Est. completion date: August 2016

Study information

• Verified date: April 2017
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Stroke

Intervention

Device:
• Automated Cardiac Event Recorder
Automated Cardiac Event Recorder to be worn continuously for one week.
• Personal Heart Rhythm Monitor
Personal Heart Rhythm Monitor to be used twice-daily for three months.

Locations

Country	Name	City	State
United Kingdom	Royal Surrey County Hospital NHS Foundation Trust	Guildford	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
University of Surrey	Royal Surrey County Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		18 months
Secondary	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).		18 months
Secondary	The sensitivity and specificity of serum biomarkers to detect cases of PAF.		18 months
Secondary	The sensitivity and specificity of markers of left atrial function to predict PAF.		18 months
Secondary	The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period.		18 months
Secondary	Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals.		30 months
Secondary	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.	30 months
Secondary	Referrals to secondary care for suspected AF/palpitations	The number of referrals to secondary care for suspected PAF will be analysed.	18 months
Secondary	Participant satisfaction with the devices used in the study.		18 months

External Links

•   HASTE Academy website
•   HASTE charity website