Embolic Stroke of Undetermined SourcePROPhecyNCT03712865
Thirty Day Heart Monitoring for Detection of Atrial Fibrillation Among Cryptogenic Stroke Patients
An observational study of Embolic Stroke of Undetermined Source, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Embolic Stroke of Undetermined Source
- How many people
- 232 participants
- Where
- 1 siteCanada
- Study dates
- 19 Nov 2015to 3 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Validation of Predictive Features of Paroxysmal Atrial Fibrillation: The Vancouver Stroke Program Pilot Study
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
Read the 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.
- Conditions
- Embolic Stroke of Undetermined Source
- Keywords
- embolic stroke, cryptogenic, atrial fibrillation, long term cardiac rhythm monitoring
- Medical subject headings
- Embolic Stroke, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
Secondary outcomes (1)
Predictive value of "high-risk" holter and echocardiogram features and presence of atrial fibrillation/atrial flutter
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start19 Nov 2015
- Primary completion3 Mar 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embolic Stroke of Undetermined SourceStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Thalia Field, University of British Columbia
- Investigators
- Thalia S Field, MD FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712865
- Sponsor's protocol ID
- H15-00183
- Acronym
- PROPhecy
- Status last verified
- May 2022
- First submitted
- 17 Oct 2018
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of Predictive Features of Paroxysmal Atrial Fibrillation: The Vancouver Stroke Program Pilot Study
- ClinicalTrials.gov ID
- NCT03712865
- Acronym / sponsor ID
- PROPhecy / H15-00183
- Conditions
- Embolic Stroke of Undetermined Source
- Keywords
- embolic stroke, cryptogenic, atrial fibrillation, long term cardiac rhythm monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
- 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).
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Predictive value of "high-risk" holter and echocardiogram features and presence of atrial fibrillation/atrial flutter
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thalia S Field, MD FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Embolic Stroke of Undetermined Source, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Atrial Fibrillation/Atrial Flutter (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.