Post-Embolic Rhythm Detection With Implantable Versus External Monitoring (PERDIEM)
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|ClinicalTrials.gov Identifier: NCT02428140|
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : November 10, 2020
The overall aim of this trial is to determine the most cost effective approach to diagnose paroxysmal atrial fibrillation (PAF) following transient ischemic attack (TIA) and stroke.
A summary of the rationale for this study is as follows:
- Recently completed randomized trials of cardiac monitoring following stroke have established that PAF is more common than previously recognized in cryptogenic stroke.
- The majority of TIA/stroke patients will have at least one potential stroke mechanism identified by the time etiologic investigations completed.
- Detecting PAF in patients with strokes with known causes (eg. lacunar and large vessel atherosclerosis) is clinically important since appropriate anticoagulation for AF reduces stroke recurrence in all patients with prior TIA/stroke not just cryptogenic strokes.
- There are competing technologies for evaluating cardiac rhythm and diagnosing AF but no cost effectiveness data
- The rates of PAF in strokes with known causes (SKC) have not been well characterized.
PER-DIEM is a pilot study to compare two different cardiac monitoring technologies as first-line investigations to detect PAF in patients with recent stroke and TIA. The study will also assess whether a pivotal trial is feasible and warranted.
The principal research questions to be addressed in this study will be:
- Whether implantable loop recorder (ILR) plus remote monitoring will diagnose more paroxysmal AF / atrial flutter and provide a better assessment of the total burden of AF resulting in a greater proportion of patients started on an OAC versus the external loop recorder (ELR) strategy.
- What is the relative cost-effectiveness as a first-line investigation of long-term implantable ECG (ILR) coupled with remote monitoring for 12 months compared to external event-triggered ECG loop recorder (ELR) for 30 days in the diagnosis clinically actionable AF in following TIA/stroke.
2) What is the feasibility, patient compliance, diagnostic accuracy and rates of AF detection (>30 seconds) of ILR compared to the ELR strategies.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Atrial Fibrillation Arrhythmias, Cardiac||Device: Medtronic Reveal LINQ Device: Sorin Spiderflash-t||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post-Embolic Rhythm Detection With Implantable Versus External Monitoring: Pilot and Feasibility Study|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2019|
Experimental: Implanted Loop Recorder
long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months
Device: Medtronic Reveal LINQ
Experimental: External Loop Recorder
external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days
Device: Sorin Spiderflash-t
- Detection of clinically actionable AF [ Time Frame: 12 months ]The primary outcome will be the rate of detection of an atrial arrhythmia (AF / atrial flutter) that results in initiation of additional anti-platelet or OAC therapy as per usual clinical practice.
- Detection of clinically actionable AF or death [ Time Frame: 12, 24, 36 months ]The first secondary outcome will be the composite of detection of an atrial arrhythmia (AF / atrial flutter) that results in initiation of additional anti-platelet or OAC therapy as per usual clinical practice or death (whichever occurs first).
- Compliance [ Time Frame: 30 days, 12 months ]Compliance with assigned therapy (accept ILR, conduct at least 80% of ELR assessments)
- Costs of cardiac and non-cardiac investigations [ Time Frame: 12, 24, 36 months ]Costs for all cardiac and non-cardiac investigations related to etiologic workup of index stroke / TIA.
- Duration of any detected atrial fibrillation / atrial flutter. [ Time Frame: 30 days, 6 months, 12, 24, 36 months ]Total duration of any detected atrial fibrillation / atrial flutter.
- Study related adverse events / serious adverse events. [ Time Frame: 30 days, 6, 12, 24, 36 months ]Study related adverse events / serious adverse events.
- Ischemic stroke / TIA, death, hemorrhagic stroke, major adverse bleeding, or death. [ Time Frame: 30 days, 6, 12, 24, 36 months ]Clinical recurrence of ischemic stroke / TIA, death, hemorrhagic stroke, major adverse bleeding, or death.
- Clinical silent strokes, microbleeds, white matter disease [ Time Frame: 12, 24 months ]Relationship between duration detected AF and clinically silent strokes, volume of leukoaraiosis, numbers of cerebral microbleeds
- Predictors of AF detection [ Time Frame: 12, 24 months ]Association between baseline clinical characteristics (e.g. comorbidities, burden of supraventricular ectopy on Holter, left atrial dimension) and subsequent detection of AF
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): NCT02428140
|Foothills Medical Centre|
|Calgary, Alberta, Canada, T2N 2T9|
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G 2B7|
|Grey Nuns Community Hospital|
|Edmonton, Alberta, Canada, T6L5X8|
|Principal Investigator:||Brian H Buck, MD, MSc||University of Alberta|