Thirty Day Heart Monitoring for Detection of Atrial Fibrillation Among Cryptogenic Stroke Patients

NCT03712865 | Completed

• 1 other identifier: H15-00183
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

The PROPhecy study aims to detect the presence of atrial fibrillation/flutter in patients who have suffered an embolic stroke of undetermined source (ESUS) using 30 day cardiac monitoring. We hypothesize that the presence of any of the following features on long-term heart rhythm monitoring (holter monitoring) or heart ultrasound (transthoracic echocardiogram), either individually or in combination, will have additional predictive value for the detection of atrial fibrillation lasting 30 seconds or longer on 30 day holter monitoring:

• greater than 100 premature atrial beats in 24 hours
• greater than 2 runs of atrial tachycardia (4 or more non-sinus beats) in 24 hours
• Left atrial enlargement on transthoracic echocardiogram

Conditions

Embolic Stroke of Undetermined Source

Keywords

embolic stroke; cryptogenic; atrial fibrillation; long term cardiac rhythm monitoring

Outcome Measures

Primary Outcomes (1)

• Detection of Atrial Fibrillation/Atrial Flutter

  Our primary outcome is new detection of atrial fibrillation/atrial flutter lasting 30 seconds or longer after 30 days of cardiac monitoring. Holter and echocardiography reports will be examined for features identified as being significantly associated with a new diagnosis of atrial fibrillation/flutter on univariate analysis in the EMBRACE trial: ((1) \>100 premature atrial beats in 24 hours, (2) two or more runs of 4 atrial beats or more in 24 hours, or (3) left atrial volume index \>26 mL/m2 on transthoracic echocardiography) will be compared against controls with "benign" holters and echocardiograms (ie. Those with \<100 premature atrial beats in 24h, 1 or fewer runs of atrial tachycardia, and lacking left atrial enlargement).

  30 days

Secondary Outcomes (1)

• Predictive value of "high-risk" holter and echocardiogram features and presence of atrial fibrillation/atrial flutter

  30 days

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients age 55 years and older who have had an embolic stroke of undetermined source (ESUS). Participants will be recruited from the stroke ward at Vancouver General Hospital (VGH) and the Stroke Prevention Clinic at VGH.

You may qualify if:

• Age 55 or over
• Diagnosis of the index event made by a stroke specialist of an acute ischemic stroke or TIA (WHO definition) of undetermined etiology occurring within the previous 6 months (180 days). The event must be either:
• An embolic arterial ischemic stroke confirmed by neuroimaging; or,
• A clinical 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).
• No previous ECG or Holter monitor showing atrial fibrillation (AF) or atrial flutter
• Informed consent from patient or legally authorized representative if patient is not competent due to stroke-related cognitive impairment, aphasia or anosognosia
• Patient has undergone, as per standard of care, routine CT head, vascular imaging (CT angiogram or, if GFR \<30 mL/min, carotid dopplers) and echocardiography is planned within 60 days of the index event. (NOTE: if echocardiogram has already been performed within one year prior to study enrolment, it may serve as the baseline echocardiogram for study purposes).
• Patient is expected to survive at least 6 months

You may not qualify if:

• Unable to participate in follow up in Vancouver
• Atrial fibrillation/flutter by history or on holter, ECG or telemetry
• Retinal stroke/TIA
• Most responsible etiological diagnosis for the qualifying stroke/TIA event already determined, i.e. probable small-vessel (lacunar) disease, probable large-vessel disease, cervicocephalic artery dissection, venous sinus thrombosis, hypercoagulable states, or other known cause
• Major-risk cardioembolic source on echocardiography (intracardiac thrombus, endocarditis, mechanical heart valve, rheumatic mitral valve disease OR Positive blood cultures at the time of the index event (i.e. more than 2 bottles at two sites or collected at different times positive for pathogen)
• Planned carotid endarterectomy within the next 90 days
• Concurrent indication for cardiac monitoring, pacemaker or implanted cardiac defibrillator
• Known skin reactions to synthetic polymers, hydrogel or skin breakdown at the site for extended monitor application

Sponsors & Collaborators

• University of British Columbia: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Vancouver Stroke Program

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Embolic Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Ischemic Stroke; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thalia S Field, MD FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: November 19, 2015
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)