Clinical trial NCT02428140: Post-Embolic Rhythm Detection With Implantable Versus External Monitoring
Official title: Post-Embolic Rhythm Detection With Implantable Versus External Monitoring: Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Atrial Fibrillation
Arrhythmias, Cardiac
Keywords: ischemic stroke
atrial fibrillation
etiologic investigations
secondary prevention
anticoagulation
arrhythmias
embolic stroke, undetermined etiology
implantable loop recorder
external loop recorder
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: Alberta Innovates Health Solutions
name: Medtronic
First posted: 2015-04-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Definite AF or Highly Probable AF
timeFrame: 12 months
Secondary outcomes:
measure: AF Lasting ≥2 Min or Death by 12 Months
timeFrame: 12 months
measure: TIA
timeFrame: 12 months
measure: Recurrent Stroke
timeFrame: 12 months
measure: Hemorrhage
timeFrame: 12 months
measure: Death
timeFrame: 12 months
measure: Oral Anticoagulation Therapy
timeFrame: 12 months
measure: ≥1 Serious Adverse Event
timeFrame: 12 months
measure: Compliance
timeFrame: 12 months
measure: Costs of Cardiac and Non-cardiac Investigations
timeFrame: 12 months
measure: Duration of Any Detected Atrial Fibrillation / Atrial Flutter.
timeFrame: 12 months
Other outcomes:
measure: Predictors of AF Detection
timeFrame: 12 months
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Brian H Buck, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.