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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. David Gladstone, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00846924
First received: February 18, 2009
Last updated: September 19, 2014
Last verified: September 2014
  Purpose

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.)


Condition Intervention
Stroke
Transient Ischemic Attack
Atrial Fibrillation
Atrial Flutter
Device: a 30-day ambulatory cardiac event monitor
Device: 24-hour Holter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Atrial fibrillation <30 seconds [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Atrial flutter <30 seconds [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of atrial fibrillation) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Proportion of patients in each group that are prescribed oral anticoagulation, as assessed at the 90-day follow-up [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 564
Study Start Date: May 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: repeat 24-hour Holter monitor Device: 24-hour Holter
Repeat standard 24-hour Holter Monitor
Other Name: Performed as per individual hospital routines
Experimental: 30-day ambulatory cardiac event monitor Device: a 30-day ambulatory 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.
Other Name: AccuHeart Electrode Belt, Braemar ER 910AF (cardiac event monitor)

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. 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).
  2. 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.
  3. 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.
  4. 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.]
  5. 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]
  6. 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).
  7. The patient is expected to survive at least 6 months.
  8. The patient has a valid provincial health insurance number.

    • The index event will be defined as the event leading to medical presentation

Exclusion:

  1. 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
  2. Exclusively retinal stroke or TIA event.
  3. 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.
  4. Planned carotid endarterectomy within 90 days.
  5. Patient is already currently participating in a clinical trial involving an investigational medication or device.*
  6. Any finding on echocardiography for which there is already an evidence-based indication for long-term anticoagulation (e.g. mechanical heart valve, thrombus, etc.).
  7. Endocarditis
  8. Pacemaker or ICD device.
  9. 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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846924

Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada
Grey Nuns Hospital
Edmonton, Alberta, Canada
Walter C. Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver Hospital and Health Sciences Centre
Vancouver, British Columbia, Canada
Vancouver Island Health Research Centre (VIHA)
Victoria, British Columbia, Canada
Canada, Ontario
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
Robarts Research Institute
London, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital Research Institute -The Ottawa Hospital
Ottawa, Ontario, Canada
Thunder Bay Regional HSC
Thunder Bay, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
UHN / Toronto Western Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
York Central Hospital
Toronto, Ontario, Canada
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada
CHA-Hôpital de l'Enfant-Jesus
Quebec City, Quebec, Canada
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: David J Gladstone, MD, PhD, FRCPC Sunnybrook Health Sciences Centre
  More Information

No publications provided by Sunnybrook Health Sciences Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. David Gladstone, Study Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00846924     History of Changes
Other Study ID Numbers: Embrace001
Study First Received: February 18, 2009
Last Updated: September 19, 2014
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Stroke
Transient Ischemic Attack
Atrial fibrillation
Atrial flutter

Additional relevant MeSH terms:
Atrial Fibrillation
Ischemia
Ischemic Attack, Transient
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014