Thirty Day Heart Monitoring for Detection of Atrial Fibrillation Among Cryptogenic Stroke Patients (PROPhecy)
|ClinicalTrials.gov Identifier: NCT03712865|
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
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|
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 Type :||Observational|
|Estimated Enrollment :||150 participants|
|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|
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712865
|Canada, British Columbia|
|Vancouver Stroke Program|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Principal Investigator:||Thalia S Field, MD FRCPC||University of British Columbia|