Condition category
Circulatory System
Date applied
18/03/2010
Date assigned
28/04/2010
Last edited
18/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Atrial fibrillation is a heart condition that causes an irregular heart rate. It can cause blood clots in the heart, which can break up, escape from the heart and become lodged in the blood vessels supplying the brain, causing a stroke. Stroke patients with atrial fibrillation are therefore at a higher risk of having another stroke, but atrial fibrillation is not always identified by the standard investigations performed after a stroke. An electrocardiogram (ECG) is a simple test to check the heart's rhythm and electrical activity. The aim of this study is to find out whether additional ECG monitoring early after stroke speeds up the detection of atrial fibrillation and the start of effective treatment.

Who can participate?
Patients who have had a stroke in the last week

What does the study involve?
Participants are randomly allocated to one of two groups. One group receives standard care, and the other group receives additional ECG monitoring (two additional 12-lead ECGs plus 3 to 7 days' continuous ECG event monitoring). We assess the number of patients with detected atrial fibrillation and starting treatment for atrial fibrillation, the costs of investigation and treatment, patient acceptability, stroke recurrence, quality of life and survival in the two groups.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Western Infirmary (UK)

When is the study starting and how long is it expected to run for?
May 2010 to December 2016

Who is funding the study?
Chief Scientist Office of the Scottish Executive Health Department (UK)

Who is the main contact?
Prof. Kennedy Lees
k.r.lees@clinmed.gla.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kennedy R Lees

ORCID ID

Contact details

Acute Stroke Unit & Cerebrovascular Clinic
Western Infirmary
44 Church Street
and
Cardiovascular & Medical Sciences
Faculty of Medicine
University of Glasgow
Glasgow
G11 6NT
United Kingdom
-
k.r.lees@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation of electrocardiographic monitoring strategy to identify atrial fibrillation in patients with recent acute stroke: a randomised controlled trial

Acronym

Study hypothesis

Intensive investigation for atrial fibrillation amongst patients with acute stroke or confirmed transient ischaemic attack (TIA) who are admitted or initially assessed in sinus rhythm will detect 5% who have unrecognised episodes of atrial fibrillation/flutter; and 3.5% who will be suitable to commence oral anticoagulation, rendering a policy of more intensive investigation cost-effective in the NHS.

Ethics approval

Scotland A Research Ethics Committee, 17/08/2009, ref: 09/MRE00/59

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Ischaemic stroke

Intervention

Control: standard care
Intervention: two additional 12-lead ECGs plus 3 - 7 days' continuous ECG event monitoring

Duration of intervention: 7 days
Duration of follow-up: 1 year direct; 5 years electronic

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Absolute number of patients with AF or atrial flutter detected within two weeks of stroke.

Secondary outcome measures

Secondary outcomes:
1. Absolute number of patients with AF or atrial flutter detected within 90 days and one year of stroke
2. Absolute number of patients commenced on oral anticoagulation within two weeks and one year of stroke
3. Marginal cost of investigation
4. Marginal cost of treatment
5. Patient acceptability
6. Time to recognition of AF/flutter

Tertiary outcomes:
1. Stroke recurrence within one year
2. Distribution of modified Rankin scale at one year (assessed centrally by recorded interview to ensure objectivity)
3. 'Home time' over 90 days - an objective measure of early functional outcome
4. EQ-5D quality of life at one year (in patients who can complete this, or by proxy)
5. Five-year survival (by flagging with ONS)
6. Predictors of AF amongst eligible patients
7. AF duration 'threshold' for use of anticoagulation

Overall trial start date

01/05/2010

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of acute ischaemic stroke or confirmed transient ischaemic attack, within one week of symptom onset (participants are of any age and sex)
2. Brain imaging completed prior to enrolment is consistent with acute ischaemic damage and has excluded an alternative cause for symptoms
3. Sinus rhythm on screening ECG
4. Consent to participate from patient or approved proxy

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

5000

Participant exclusion criteria

1. Clinical decision or expressed refusal to consider long term anticoagulation at a future date if cardio-embolism may be diagnosed
2. Pre-morbid condition or concomitant disease that would render subsequent secondary prevention of stroke inappropriate
3. Documented atrial fibrillation in past
4. Known durable cardiac source of embolism (eg mitral stenosis) or left ventricular akinesia, that would represent an indication for anticoagulation
5. Existing treatment with long term anticoagulation
6. Unlikely to be available for completion of study procedures

Recruitment start date

01/05/2010

Recruitment end date

31/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Western Infirmary
Glasgow
G11 6NT
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow & Clyde (UK)

Sponsor details

Research and Development Central Office
Western Infirmary
1st Floor
Tennent Institute
38 Church Street
Glasgow
G11 6NT
United Kingdom

Sponsor type

Government

Website

http://www.nhsggc.org.uk/r&d

Funders

Funder type

Government

Funder name

Chief Scientist Office

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23899913

Publication citations

  1. Results

    Higgins P, MacFarlane PW, Dawson J, McInnes GT, Langhorne P, Lees KR, Noninvasive cardiac event monitoring to detect atrial fibrillation after ischemic stroke: a randomized, controlled trial., Stroke, 2013, 44, 9, 2525-2531, doi: 10.1161/STROKEAHA.113.001927.

Additional files

Editorial Notes

18/03/2016: Plain English summary added.