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StrokeEMBRACENCT00846924

30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event

A study testing a 30-day ambulatory cardiac event monitor and 24-hour Holter in people with Stroke and Transient Ischemic Attack, run by Sunnybrook Health Sciences Centre at 17 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Atrial fibrillation is the most common cardiac cause of ischemic stroke. Detecting atrial fibrillation after a stroke or TIA is critical because highly effective secondary stroke prevention therapy is available for individuals who are recognized to have atrial fibrillation. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
a 30-day ambulatory cardiac event monitor and 24-hour Holter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
564 participants
Where
17 sitesCanada
Study dates
May 2009to 30 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of the index event* made by a stroke specialist of an acute ischemic stroke or TIA (WHO definition) of undetermined etiology (cryptogenic) occurring within the previous 6 months (180 days).The event must be either:
  • an embolic arterial ischemic stroke confirmed by neuroimaging; or
  • a transient ischemic attack, defined as involving a focal unilateral motor deficit, speech/language deficit, or hemianopia, with symptom duration <24 hours (note: amaurosis fugax/transient monocular blindness, pure sensory spells, isolated vertigo spells, etc. do not qualify for enrolment given the potential for misdiagnosis of such events).
  • Patient meets the following:
  • At least one 12-lead ECG has already been obtained as part of the routine clinical post-stroke/TIA work-up, and no ECGs have shown any episodes of atrial fibrillation or atrial flutter, and;
  • A Holter monitor has already been obtained as part of the routine clinical post-stroke/TIA work-up, and does not show any episodes of atrial fibrillation or atrial flutter ≥30 seconds.
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  • The patient is being actively investigated for the etiology of the stroke/TIA event and additional cardiac monitoring is desired to screen further for the possibility of occult paroxysmal atrial fibrillation/flutter, i.e. patients selected for this study are those for whom the investigator, in his/her clinical judgment, would consider ordering a repeat Holter monitor as part of clinical care.
  • The following diagnostic tests have already been completed as part of clinical routine post-stroke/TIA:
  • brain imaging with CT or MRI,
  • vascular imaging of the extracranial and intracranial circulation with either CT angiography or MR angiography to exclude significant large vessel occlusive disease as the most likely mechanism for the index ischemic event (carotid Doppler ultrasound is acceptable for those presenting with anterior circulation ischemic events),
  • transthoracic (or transesophageal) echocardiography to exclude thrombus or other structural heart disease that in the opinion of the investigator is the most likely cause for the stroke/TIA event. [Note: If a baseline echocardiogram cannot be obtained clinically after the index event and prior to study enrollment, then it is acceptable for study purposes for an echocardiogram to be obtained after patient enrollment into the study but prior to the 90-day follow-up visit. Alternatively, an echocardiogram already performed within one year prior to study enrollment may serve as the baseline echocardiogram for study purposes.]
  • Age 55 years or older [Note: Participants aged 55-59 years should have imaging confirmation of the index stroke/TIA event with an embolic imaging pattern of acute cerebral ischemia]
  • Informed consent from the patient (or from a legally authorized representative if the patient is not competent, e.g. due to stroke-related cognitive impairment, aphasia, or anosognosia).
  • The patient is expected to survive at least 6 months.
  • The patient has a valid provincial health insurance number.
  • The index event will be defined as the event leading to medical presentation

Who cannot join

  • Any previously documented atrial fibrillation or atrial flutter, i.e. a past history of atrial fibrillation/flutter or atrial fibrillation/flutter detected on ECG, Holter, or telemetry following the index stroke/TIA event (a remote history of transient perioperative atrial fibrillation is not exclusionary
  • Exclusively retinal stroke or TIA event.
  • A most responsible etiological diagnosis for the qualifying stroke/TIA event has already been determined, i.e. probable small-vessel (lacunar) disease, probable large vessel disease, cervicocephalic artery dissection, venous sinus thrombosis, hypercoagulable states, or other known cause.
  • Planned carotid endarterectomy within 90 days.
  • Patient is already currently participating in a clinical trial involving an investigational medication or device.*
  • Any finding on echocardiography for which there is already an evidence-based indication for long-term anticoagulation (e.g. mechanical heart valve, thrombus, etc.).
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  • Endocarditis
  • Pacemaker or ICD device.
  • Patients with known skin reactions to synthetic polymers or to silver. (Some people who display sensitivity to silver jewellery are sensitive to the impurities present in silver alloys and not to the silver itself. These people may participate.)

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Canada17 sites

  • Foothills Medical Centre

    Calgary, Alberta

  • Grey Nuns Hospital

    Edmonton, Alberta

  • Walter C. Mackenzie Health Sciences Centre

    Edmonton, Alberta

  • Hamilton Health Sciences Centre

    Hamilton, Ontario

  • Kingston General Hospital

    Kingston, Ontario

  • London Health Sciences Centre

    London, Ontario

  • Robarts Research Institute

    London, Ontario

  • Montreal General Hospital

    Montreal, Quebec

  • Ottawa Hospital Research Institute -The Ottawa Hospital

    Ottawa, Ontario

  • CHA-Hôpital de l'Enfant-Jesus

    Québec, Quebec

  • Thunder Bay Regional HSC

    Thunder Bay, Ontario

  • St. Michael's Hospital

    Toronto, Ontario

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • UHN / Toronto Western Hospital

    Toronto, Ontario

  • York Central Hospital

    Toronto, Ontario

  • Vancouver Hospital and Health Sciences Centre

    Vancouver, British Columbia

  • Vancouver Island Health Research Centre (VIHA)

    Victoria, British Columbia

Other trials in Canada

About this study

Official title: 30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event: A Randomized Controlled Trial

Atrial fibrillation is the most common cardiac cause of ischemic stroke. Detecting atrial fibrillation after a stroke or TIA is critical because highly effective secondary stroke prevention therapy is available for individuals who are recognized to have atrial fibrillation. However, atrial fibrillation is likely under-diagnosed after stroke and TIA because atrial fibrillation is often difficult to detect as it is frequently paroxysmal and asymptomatic, and patients do not routinely undergo prolonged screening. The purpose of this study is to determine the diagnostic yield of a novel 30-day cardiac event monitor compared to a repeat 24-hour Holter monitor for detecting occult paroxysmal atrial fibrillation in patients with a recent ischemic stroke or TIA of undetermined etiology after completion of a standard clinical stroke work-up (including an initial negative Holter monitor.)

Being tested
a 30-day ambulatory cardiac event monitor, 24-hour Holter
Keywords
Stroke, Transient Ischemic Attack, Atrial fibrillation, Atrial flutter
Medical subject headings
Stroke, Ischemic Attack, Transient, Atrial Fibrillation, Atrial Flutter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • a 30-day ambulatory cardiac event monitorDevice

    Also called AccuHeart Electrode Belt, Braemar ER 910AF (cardiac event monitor)

    Patients will be fitted with dry electrode belt (including cardiac event monitor)and instructed to wear the device for as many hours(waking and sleeping) each day as possible, for a total of 30 days.

  • 24-hour HolterDevice

    Also called Performed as per individual hospital routines

    Repeat standard 24-hour Holter Monitor

Study groups in NCT00846924
Study groupRoleWhat they receive
repeat 24-hour Holter monitorActive comparatorNot described
Receives: Device: 24-hour Holter
30-day ambulatory cardiac event monitorExperimentalNot described
Receives: Device: a 30-day ambulatory cardiac event monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds, as assessed at the 90 day follow-up

    Measured: 90 days

Secondary outcomes (7)

  1. Atrial fibrillation <30 seconds

    Measured: 90 days

  2. Atrial flutter <30 seconds

    Measured: 90 days

  3. Non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of atrial fibrillation)

    Measured: 90 days

  4. Proportion of patients in each group that are prescribed oral anticoagulation, as assessed at the 90-day follow-up

    Measured: 90 days

  5. Patient adherence with 30-day monitoring: average proportion of days wearing the monitor per patient, and the percentage of patients wearing the monitor for >75% of the target period

    Measured: 90 days

  6. 1 and 2-year recurrence of ischemic stroke/TIA, death, hemorrhagic stroke, major adverse bleeding event, detection of atrial fibrillation outside of the study protocol

    Measured: 2 years

  7. composite endpoint of: (1) AF >30 seconds, (2) non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of AF), or (3) atrial flutter.

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionApr 2014
  4. Study completion30 Oct 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
564 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00846924
Sponsor's protocol ID
Embrace001
Acronym
EMBRACE
Status last verified
Oct 2018
First submitted
18 Feb 2009
Last updated
5 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • Gladstone DJ, Dorian P, Spring M, Panzov V, Mamdani M, Healey JS, Thorpe KE; EMBRACE Steering Committee and Investigators. Atrial premature beats predict atrial fibrillation in cryptogenic stroke: results from the EMBRACE trial. Stroke. 2015 Apr;46(4):936-41. doi: 10.1161/STROKEAHA.115.008714. Epub 2015 Feb 19.

    PubMed 25700289

  • Gladstone DJ, Spring M, Dorian P, Panzov V, Thorpe KE, Hall J, Vaid H, O'Donnell M, Laupacis A, Cote R, Sharma M, Blakely JA, Shuaib A, Hachinski V, Coutts SB, Sahlas DJ, Teal P, Yip S, Spence JD, Buck B, Verreault S, Casaubon LK, Penn A, Selchen D, Jin A, Howse D, Mehdiratta M, Boyle K, Aviv R, Kapral MK, Mamdani M; EMBRACE Investigators and Coordinators. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014 Jun 26;370(26):2467-77. doi: 10.1056/NEJMoa1311376.

    PubMed 24963566

Questions about this trial

What is this clinical trial studying?

A study testing a 30-day ambulatory cardiac event monitor and 24-hour Holter in people with Stroke and Transient Ischemic Attack, run by Sunnybrook Health Sciences Centre at 17 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds, as assessed at the 90 day follow-up (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00846924, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.

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