An observational study in Embolic Stroke of Undetermined Source, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University of British Columbia · Observational
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:
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.
40 studies on the registry are indexed under Embolic Stroke; 11 are open to participants now.
This study's enrollment of 232 is below the median of 364 across 27 observational studies indexed under Embolic Stroke.
Browse Embolic Stroke studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of the index event made by a stroke specialist of an acute ischemic stroke or (WHO definition) of undetermined etiology occurring within the previous 6 months (180 days). The event must be either:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Time frame: 30 days
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.
Time frame: 30 days
Plan to share: No
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Ran from Nov 2015 to primary completion in Mar 2022, 75 months.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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