Post-Embolic Rhythm Detection With Implantable Versus External Monitoring (PERDIEM)
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|ClinicalTrials.gov Identifier: NCT02428140|
Recruitment Status : Active, not recruiting
First Posted : April 28, 2015
Last Update Posted : May 1, 2018
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:
- 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.
- 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|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated 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
- Cost-effectiveness [ Time Frame: 12 months ]1. Cost-effectiveness as a first line investigation of long-term implantable ECG (ILR) coupled with remote monitoring for 12 months versus an external event-triggered ECG loop recorder (ELR) for 30 days in the diagnosis clinically actionable AF in following TIA/stroke.
- Detection of atrial arrhythmia (AF / atrial flutter) that results in initiation of additional anti-platelet or oral anticoagulant therapy as per usual clinical practice. [ Time Frame: 12, 24, 36 months ]
- Compliance with assigned therapy (accept ILR, conduct at least 80% of ELR assessments) [ Time Frame: 30 days, 12 months ]
- Costs for all cardiac and non-cardiac investigations related to etiologic workup of index stroke / TIA. [ Time Frame: 12 months ]
- Total duration of any detected atrial fibrillation / atrial flutter. [ Time Frame: 30 days, 6 months, 12, 24, 36 months ]
- Study related adverse events / serious adverse events. [ Time Frame: 30 days, 6, 12, 24, 36 months ]
- Clinical recurrence of ischemic stroke / TIA, death, hemorrhagic stroke, major adverse bleeding, or death. [ Time Frame: 30 days, 6, 12, 24, 36 months ]
- Relationship between duration detected AF and clinically silent strokes, volume of leukoaraiosis, numbers of cerebral microbleeds [ Time Frame: 36 months ]
- Presence of cognitive impairment, progression, and relationship to AF [ Time Frame: 12 and 36 months ]
- Association between baseline clinical characteristics (e.g. comorbidities, burden of supraventricular ectopy on Holter, left atrial dimension) and subsequent detection of AF [ Time Frame: 12 months ]
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|