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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
Sponsor:
Collaborators:
University of Calgary
Alberta Innovates Health Solutions
Medtronic
Information provided by (Responsible Party):
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. 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.

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
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
Study Start Date : July 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. Compliance with assigned therapy (accept ILR, conduct at least 80% of ELR assessments) [ Time Frame: 30 days, 12 months ]
  3. Costs for all cardiac and non-cardiac investigations related to etiologic workup of index stroke / TIA. [ Time Frame: 12 months ]
  4. Total duration of any detected atrial fibrillation / atrial flutter. [ Time Frame: 30 days, 6 months, 12, 24, 36 months ]
  5. Study related adverse events / serious adverse events. [ Time Frame: 30 days, 6, 12, 24, 36 months ]
  6. Clinical recurrence of ischemic stroke / TIA, death, hemorrhagic stroke, major adverse bleeding, or death. [ Time Frame: 30 days, 6, 12, 24, 36 months ]

Other Outcome Measures:
  1. Relationship between duration detected AF and clinically silent strokes, volume of leukoaraiosis, numbers of cerebral microbleeds [ Time Frame: 36 months ]
  2. Presence of cognitive impairment, progression, and relationship to AF [ Time Frame: 12 and 36 months ]
  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Canada, Alberta
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
Sponsors and Collaborators
University of Alberta
University of Calgary
Alberta Innovates Health Solutions
Medtronic
Investigators
Principal Investigator: Brian H Buck, MD, MSc University of Alberta

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02428140     History of Changes
Other Study ID Numbers: 00051629
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: October 2017

Keywords provided by University of Alberta:
ischemic stroke
atrial fibrillation
etiologic investigations
secondary prevention
anticoagulation
arrhythmias
embolic stroke, undetermined etiology
implantable loop recorder
external loop recorder

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes