Post-Embolic Rhythm Detection With Implantable Versus External Monitoring (PERDIEM)

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation; Arrhythmias, Cardiac
• Intervention / Treatment: Device: Medtronic Reveal LINQ; Device: Sorin Spiderflash-t

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
    • Edmonton, Alberta, Canada, T6L5X8
      • Grey Nuns Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Definite AF or Highly Probable AF	Definite AF or highly probable AF (adjudicated new AF lasting ≥2 minutes within 12 months of randomization)	12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors of AF Detection	Association between baseline clinical characteristics (e.g. comorbidities, burden of supraventricular ectopy on Holter, left atrial dimension) and subsequent detection of AF	12 months

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: University of Calgary; Alberta Innovates Health Solutions; Medtronic
• Investigators: Principal Investigator: Brian H Buck, MD, MSc, University of Alberta

Publications and helpful links

General Publications

• Buck BH, Hill MD, Quinn FR, Butcher KS, Menon BK, Gulamhusein S, Siddiqui M, Coutts SB, Jeerakathil T, Smith EE, Khan K, Barber PA, Jickling G, Reyes L, Save S, Fairall P, Piquette L, Kamal N, Chew DS, Demchuk AM, Shuaib A, Exner DV. Effect of Implantable vs Prolonged External Electrocardiographic Monitoring on Atrial Fibrillation Detection in Patients With Ischemic Stroke: The PER DIEM Randomized Clinical Trial. JAMA. 2021 Jun 1;325(21):2160-2168. doi: 10.1001/jama.2021.6128.

Helpful Links

• Final Publication

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: April 23, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimated): April 28, 2015

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: atrial fibrillation; ischemic stroke; anticoagulation; secondary prevention; arrhythmias; implantable loop recorder; etiologic investigations; embolic stroke, undetermined etiology; external loop recorder
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: 00051629