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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.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| repeat 24-hour Holter monitor | Active Comparator |
| |
| 30-day ambulatory cardiac event monitor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a 30-day ambulatory cardiac event monitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds, as assessed at the 90 day follow-up | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation <30 seconds | 90 days | |
| Atrial flutter <30 seconds | 90 days | |
| Non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of atrial fibrillation) |
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Inclusion:
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:
Patient meets the following:
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:
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.
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| David J Gladstone, MD, PhD, FRCPC | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | Canada | |||
| Grey Nuns Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25700289 | Derived | 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. | |
| 24963566 | Derived |
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|
| 24-hour Holter | Device | Repeat standard 24-hour Holter Monitor |
|
|
| 90 days |
| Proportion of patients in each group that are prescribed oral anticoagulation, as assessed at the 90-day follow-up | 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 | 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 | 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. | 90 days |
| Edmonton |
| Alberta |
| Canada |
| Walter C. Mackenzie Health Sciences Centre | Edmonton | Alberta | Canada |
| Vancouver Hospital and Health Sciences Centre | Vancouver | British Columbia | Canada |
| Vancouver Island Health Research Centre (VIHA) | Victoria | British Columbia | 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 |
| Ottawa Hospital Research Institute -The Ottawa Hospital | Ottawa | Ontario | 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 |
| Montreal General Hospital | Montreal | Quebec | Canada |
| CHA-Hôpital de l'Enfant-Jesus | Québec | Quebec | Canada |
| 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. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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