NCT02428140

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. 1.Recently completed randomized trials of cardiac monitoring following stroke have established that PAF is more common than previously recognized in cryptogenic stroke.
  2. 2.The majority of TIA/stroke patients will have at least one potential stroke mechanism identified by the time etiologic investigations completed.
  3. 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. 4.There are competing technologies for evaluating cardiac rhythm and diagnosing AF but no cost effectiveness data
  5. 5.The rates of PAF in strokes with known causes (SKC) have not been well characterized.
  6. 6.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.
  7. 7.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

October 1, 2021

Enrollment Period

3.4 years

First QC Date

April 23, 2015

Results QC Date

October 26, 2021

Last Update Submit

August 21, 2023

Conditions

StrokeAtrial FibrillationArrhythmias, Cardiac

Keywords

ischemic strokeatrial fibrillationetiologic investigationssecondary preventionanticoagulationarrhythmiasembolic stroke, undetermined etiologyimplantable loop recorderexternal loop recorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • AF Lasting ≥2 Min or Death by 12 Months

    12 months

  • TIA

    12 months

  • Recurrent Stroke

    12 months

  • Hemorrhage

    12 months

  • Death

    12 months

  • +5 more secondary outcomes

Other Outcomes (1)

  • Predictors of AF Detection

    12 months

Study Arms (2)

Implanted Loop Recorder

EXPERIMENTAL

long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months

Device: Medtronic Reveal LINQ

External Loop Recorder

EXPERIMENTAL

external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days

Device: Sorin Spiderflash-t

Interventions

Medtronic Reveal LINQDEVICE
Implanted Loop Recorder
Sorin Spiderflash-tDEVICE
External Loop Recorder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, T6L5X8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 34061146RESULT

MeSH Terms

Conditions

StrokeAtrial FibrillationArrhythmias, CardiacIschemic StrokeEmbolic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Brian Buck
Organization
University of Alberta
bbuck@Ualberta.ca
78024819227

Study Officials

  • Brian H Buck, MD, MSc

    University of Alberta

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

April 28, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

March 12, 2024

Results First Posted

March 12, 2024

Record last verified: 2021-10

Locations

CA(3)