Post-Embolic Rhythm Detection With Implantable Versus External Monitoring

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Stroke
• Interventions: Device: Sorin Spiderflash-t; Device: Medtronic Reveal LINQ

• Registration Number: NCT02428140
• Lead Sponsor: University of Alberta

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:

1. Recently completed randomized trials of cardiac monitoring following stroke have established that PAF is more common than previously recognized in cryptogenic stroke.

2. The majority of TIA/stroke patients will have at least one potential stroke mechanism identified by the time etiologic investigations completed.

3. 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.

4. There are competing technologies for evaluating cardiac rhythm and diagnosing AF but no cost effectiveness data

5. 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:

1. 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.

2. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-28
• Study Start: 2015-07
• Primary Completion: 2018-12
• Study Completion: 2019-12
• Status Verified: 2021-10
• Results First Submitted: 2021-10-26
• Results First Submitted QC: 2023-08-21
• Last Update Submitted: 2023-08-21
• Results First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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:

  1. an arterial ischemic stroke confirmed by neuroimaging; or
  2. 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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
External Loop Recorder	Sorin Spiderflash-t	external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days
Implanted Loop Recorder	Medtronic Reveal LINQ	long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months

Primary Outcome Measures

Name	Time	Method
Definite AF or Highly Probable AF	12 months	Definite AF or highly probable AF (adjudicated new AF lasting ≥2 minutes within 12 months of randomization)

Secondary Outcome Measures

Name	Time	Method
Recurrent Stroke	12 months	Recurrent ischemic stroke.
TIA	12 months	Transient ischemic attack.
≥1 Serious Adverse Event	12 months	Patients with ≥1 serious adverse event.
AF Lasting ≥2 Min or Death by 12 Months	12 months	Detection of atrial fibrillation lasting ≥ 2 minutes or death by 12 months.
Oral Anticoagulation Therapy	12 months	Initiation of oral anticoagulation therapy in patients with definite AF.
Compliance	12 months	Compliance with assigned therapy (accept ILR, conduct at least 80% of ELR assessments)
Hemorrhage	12 months	Intracerebral hemorrhage.
Costs of Cardiac and Non-cardiac Investigations	12 months	Costs for all cardiac and non-cardiac investigations related to etiologic workup of index stroke / TIA.
Death	12 months	Participant death.
Duration of Any Detected Atrial Fibrillation / Atrial Flutter.	12 months	Total duration of any detected atrial fibrillation / atrial flutter.

Trial Locations

Locations (3)

Grey Nuns Community Hospital; 🇨🇦 Edmonton, Alberta, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada