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

Stroke Clinical Trial

— EMBRACE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00846924
• Other study ID #: Embrace001
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2009
• Est. completion date: October 30, 2018

Study information

• Verified date: October 2018
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 564
• Est. completion date: October 30, 2018
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Ischemia
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

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.
• 24-hour Holter
Repeat standard 24-hour Holter Monitor

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Grey Nuns Hospital	Edmonton	Alberta
Canada	Walter C. Mackenzie Health Sciences Centre	Edmonton	Alberta
Canada	Hamilton Health Sciences Centre	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Robarts Research Institute	London	Ontario
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Ottawa Hospital Research Institute -The Ottawa Hospital	Ottawa	Ontario
Canada	CHA-Hôpital de l'Enfant-Jesus	Quebec City	Quebec
Canada	Thunder Bay Regional HSC	Thunder Bay	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	UHN / Toronto Western Hospital	Toronto	Ontario
Canada	York Central Hospital	Toronto	Ontario
Canada	Vancouver Hospital and Health Sciences Centre	Vancouver	British Columbia
Canada	Vancouver Island Health Research Centre (VIHA)	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of one or more episodes of atrial fibrillation or atrial flutter =30 seconds, as assessed at the 90 day follow-up		90 days
Secondary	Atrial fibrillation <30 seconds		90 days
Secondary	Atrial flutter <30 seconds		90 days
Secondary	Non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of atrial fibrillation)		90 days
Secondary	Proportion of patients in each group that are prescribed oral anticoagulation, as assessed at the 90-day follow-up		90 days
Secondary	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		90 days
Secondary	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		2 years
Secondary	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.		90 days