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

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ClinicalTrials.gov Identifier: NCT03712865
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Thalia Field, University of British Columbia

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

Condition or disease
Embolic Stroke of Undetermined Source

Detailed Description:

The PROPhecy study uses prolonged cardiac rhythm monitoring to detect atrial fibrillation/flutter in patients who have had an embolic stroke within six months, where no cause of stroke was found. Following informed consent, an external cardiac rhythm monitor will be attached to each participant. Participants will be instructed to wear the device as much as possible over the 30 day study period. If atrial fibrillation/flutter is detected before 30 days, participants may stop wearing the monitor and will be contacted to discuss changing their antithrombotic strategy for stroke secondary prevention as per standard of care. Recorded cardiac rhythm data will be transmitted for central interpretation and results will be sent to the PI, with copies provided for the patient's stroke neurologist and primary care practitioner for clinical continuity of care.

Participants will be contacted by telephone once per week for the duration of the 30 day study period. Following device return patients will be followed for two years and will receive telephone follow-ups at 90 days, 1 year, and 2 years.

The aim of the PROPhecy study is to prospectively validate those features on holter monitor and echocardiography identified as predictive of paroxysmal atrial fibrillation in patients with embolic strokes of undetermined source (ESUS). Our overall goal is to determine whether all patients with ESUS should be referred for extended rhythm monitoring, or whether these criteria can be used to refer patients more selectively for this more resource-intensive diagnostic procedure.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Validation of Predictive Features of Paroxysmal Atrial Fibrillation: The Vancouver Stroke Program Pilot Study
Actual Study Start Date : November 19, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Detection of Atrial Fibrillation/Atrial Flutter [ Time Frame: 30 days ]
    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).


Secondary Outcome Measures :
  1. Predictive value of "high-risk" holter and echocardiogram features and presence of atrial fibrillation/atrial flutter [ Time Frame: 30 days ]
    Clinical, holter and echocardiography correlates will be compared for those with and without atrial fibrillation/flutter on extended cardiac monitoring. Correlation between the "high-risk" features on holter monitoring and echocardiography identified in the EMBRACE trials (see Primary Outcome Measure description) and our prospective 30-day cardiac monitoring will be completed to assess predictive value of these features detected on cardiac diagnostic testing.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • 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:

    1. An embolic arterial ischemic stroke confirmed by neuroimaging; or,
    2. 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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): NCT03712865


Locations
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Canada, British Columbia
Vancouver Stroke Program
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Boehringer Ingelheim
Investigators
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Principal Investigator: Thalia S Field, MD FRCPC University of British Columbia

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Responsible Party: Thalia Field, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03712865     History of Changes
Other Study ID Numbers: H15-00183
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thalia Field, University of British Columbia:
embolic stroke
cryptogenic
atrial fibrillation
long term cardiac rhythm monitoring

Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes