PERDIEM: Post-Embolic Rhythm Detection With Implantable Versus External Monitoring

Sponsor

University of Alberta (Other)

Overall Status

Completed

CT.gov ID

NCT02428140

Collaborator

University of Calgary (Other), Alberta Innovates Health Solutions (Other), Medtronic (Industry)

300

Enrollment

Locations

Arms

Actual Duration (Months)

100

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Post-Embolic Rhythm Detection With Implantable Versus External Monitoring: Pilot and Feasibility Study

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Detection of clinically actionable AF [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.

Secondary Outcome Measures

Detection of clinically actionable AF or death [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 [30 days, 12 months]
Compliance with assigned therapy (accept ILR, conduct at least 80% of ELR assessments)
Costs of cardiac and non-cardiac investigations [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. [30 days, 6 months, 12, 24, 36 months]
Total duration of any detected atrial fibrillation / atrial flutter.
Study related adverse events / serious adverse events. [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. [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 [12, 24 months]
Relationship between duration detected AF and clinically silent strokes, volume of leukoaraiosis, numbers of cerebral microbleeds

Other Outcome Measures

Predictors of AF detection [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of the index event* made by a stroke specialist of an acute ischemic stroke or TIA occurring within the previous 90 days. The event must be either:

an arterial ischemic stroke confirmed by neuroimaging; or
transient ischemic attack with diffusion weighted positive lesion on MRI

At least one 12-lead ECG has already been obtained as part of the routine clinical post-stroke/TIA work-up, and no ECGs have shown any episodes of atrial fibrillation or atrial flutter
The patient is being actively investigated for the etiology of the stroke/TIA event and additional cardiac monitoring is desired to screen further for the possibility of occult paroxysmal atrial fibrillation/flutter
Age 18 years or older
Informed consent from the patient
The patient is expected to survive at least 6 months.

Exclusion Criteria:

Any previously documented atrial fibrillation or atrial flutter, i.e. a past history of atrial fibrillation/flutter or atrial fibrillation/flutter detected on ECG, Holter, or telemetry following the index stroke/TIA event (a remote history of transient perioperative atrial fibrillation is not exclusionary)
Planned carotid endarterectomy or carotid artery stenting within 90 days
Any condition for which there is already an indication for long term anticoagulation Pacemaker or implantable cardioverter defibrillator device
Work-up for stroke that has already included extended (>48 hour) external ECG (excluding telemetry)
Stroke and/or comorbid illness will prevent completion of planned follow-up assessments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foothills Medical Centre	Calgary	Alberta	Canada	T2N 2T9
2	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 2B7
3	Grey Nuns Community Hospital	Edmonton	Alberta	Canada	T6L5X8