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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02428140
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : November 10, 2020
Sponsor:
Collaborators:
University of Calgary
Alberta Innovates Health Solutions
Medtronic
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE April 23, 2015
First Posted Date  ICMJE April 28, 2015
Last Update Posted Date November 10, 2020
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2015)
Cost-effectiveness [ Time Frame: 12 months ]
1. Cost-effectiveness as a first line 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2015)
  • 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 ]
Current Other Pre-specified Outcome Measures
 (submitted: November 6, 2020)
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
Original Other Pre-specified Outcome Measures
 (submitted: April 23, 2015)
  • 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 ]
 
Descriptive Information
Brief Title  ICMJE Post-Embolic Rhythm Detection With Implantable Versus External Monitoring
Official Title  ICMJE Post-Embolic Rhythm Detection With Implantable Versus External Monitoring: Pilot and Feasibility Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Stroke
  • Atrial Fibrillation
  • Arrhythmias, Cardiac
Intervention  ICMJE
  • Device: Medtronic Reveal LINQ
  • Device: Sorin Spiderflash-t
Study Arms  ICMJE
  • Experimental: Implanted Loop Recorder
    long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months
    Intervention: Device: Medtronic Reveal LINQ
  • Experimental: External Loop Recorder
    external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days
    Intervention: Device: Sorin Spiderflash-t
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2017)
300
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2015)
200
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02428140
Other Study ID Numbers  ICMJE 00051629
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Alberta
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Alberta
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Calgary
  • Alberta Innovates Health Solutions
  • Medtronic
Investigators  ICMJE
Principal Investigator: Brian H Buck, MD, MSc University of Alberta
PRS Account University of Alberta
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP