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Completed

NCT Number: NCT02428140

Post-Embolic Rhythm Detection With Implantable Versus External Monitoring

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.

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Key information

Conditions

Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolic Stroke Heart Diseases Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medtronic Reveal LINQ

Device

Sorin Spiderflash-t

Device

Primary outcomes

  1. Definite AF or Highly Probable AF

    Time frame: 12 months

    Definite AF or highly probable AF (adjudicated new AF lasting ≥2 minutes within 12 months of randomization)

Secondary outcomes

  1. AF Lasting ≥2 Min or Death by 12 Months

    Time frame: 12 months

    Detection of atrial fibrillation lasting ≥ 2 minutes or death by 12 months.

  2. TIA

    Time frame: 12 months

    Transient ischemic attack.

  3. Recurrent Stroke

    Time frame: 12 months

    Recurrent ischemic stroke.

  4. Hemorrhage

    Time frame: 12 months

    Intracerebral hemorrhage.

  5. Death

    Time frame: 12 months

    Participant death.

  6. Oral Anticoagulation Therapy

    Time frame: 12 months

    Initiation of oral anticoagulation therapy in patients with definite AF.

  7. ≥1 Serious Adverse Event

    Time frame: 12 months

    Patients with ≥1 serious adverse event.

  8. Compliance

    Time frame: 12 months

    Compliance with assigned therapy (accept ILR, conduct at least 80% of ELR assessments)

  9. Costs of Cardiac and Non-cardiac Investigations

    Time frame: 12 months

    Costs for all cardiac and non-cardiac investigations related to etiologic workup of index stroke / TIA.

  10. Duration of Any Detected Atrial Fibrillation / Atrial Flutter.

    Time frame: 12 months

    Total duration of any detected atrial fibrillation / atrial flutter.

Other outcomes

  1. Predictors of AF Detection

    Time frame: 12 months

    Association between baseline clinical characteristics (e.g. comorbidities, burden of supraventricular ectopy on Holter, left atrial dimension) and subsequent detection of AF

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Innovates Health Solutions
  • Medtronic
  • University of Calgary

Registry information

Official study title

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

Acronym: PERDIEM

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Apr 28, 2015
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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