30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event (EMBRACE)
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|ClinicalTrials.gov Identifier: NCT00846924|
Recruitment Status : Unknown
Verified October 2018 by Dr. David Gladstone, Sunnybrook Health Sciences Centre.
Recruitment status was: Active, not recruiting
First Posted : February 19, 2009
Last Update Posted : October 5, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Stroke Transient Ischemic Attack Atrial Fibrillation Atrial Flutter||Device: a 30-day ambulatory cardiac event monitor Device: 24-hour Holter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||564 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event: A Randomized Controlled Trial|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||October 30, 2018|
|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)
- 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 ]
- Atrial fibrillation <30 seconds [ Time Frame: 90 days ]
- Atrial flutter <30 seconds [ Time Frame: 90 days ]
- Non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of atrial fibrillation) [ Time Frame: 90 days ]
- Proportion of patients in each group that are prescribed oral anticoagulation, as assessed at the 90-day follow-up [ Time Frame: 90 days ]
- 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 ]
- 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 ]
- 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 ]
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|Ages Eligible for Study:||55 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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
- 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.).
- 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.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846924
|Principal Investigator:||David J Gladstone, MD, PhD, FRCPC||Sunnybrook Health Sciences Centre|
|Responsible Party:||Dr. David Gladstone, Study Principal Investigator, Sunnybrook Health Sciences Centre|
|Other Study ID Numbers:||
|First Posted:||February 19, 2009 Key Record Dates|
|Last Update Posted:||October 5, 2018|
|Last Verified:||October 2018|
Transient Ischemic Attack
Ischemic Attack, Transient
Central Nervous System Diseases
Nervous System Diseases