StrokePERDIEMNCT02428140
Post-Embolic Rhythm Detection With Implantable Versus External Monitoring
A study testing Medtronic Reveal LINQ and Sorin Spiderflash-t in people with Stroke and Atrial Fibrillation, run by University of Alberta at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Atrial Fibrillation, Arrhythmias, Cardiac
- What is being tested?
- Medtronic Reveal LINQ and Sorin Spiderflash-t
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Grey Nuns Community Hospital
Edmonton, Alberta, T6L5X8
About this study
Official title: Post-Embolic Rhythm Detection With Implantable Versus External Monitoring: Pilot and Feasibility Study
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:
Read more
- Recently completed randomized trials of cardiac monitoring following stroke have established that PAF is more common than previously recognized in cryptogenic stroke.
- The majority of TIA/stroke patients will have at least one potential stroke mechanism identified by the time etiologic investigations completed.
- 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.
- There are competing technologies for evaluating cardiac rhythm and diagnosing AF but no cost effectiveness data
- 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:
- 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.
- 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.
- What is the feasibility, patient compliance, diagnostic accuracy and rates of AF detection (>30 seconds) of ILR compared to the ELR strategies.
- Conditions
- Stroke, Atrial Fibrillation, Arrhythmias, Cardiac
- Being tested
- Medtronic Reveal LINQ, Sorin Spiderflash-t
- Keywords
- ischemic stroke, atrial fibrillation, etiologic investigations, secondary prevention, anticoagulation, arrhythmias, embolic stroke, undetermined etiology, implantable loop recorder, external loop recorder
- Medical subject headings
- Stroke, Atrial Fibrillation, Arrhythmias, Cardiac, Ischemic Stroke, Embolic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Reveal LINQDevice
Sorin Spiderflash-tDevice
| Study group | Role | What they receive |
|---|---|---|
| Implanted Loop Recorder | Experimental | long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months Receives: Device: Medtronic Reveal LINQ |
| External Loop Recorder | Experimental | external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days Receives: Device: Sorin Spiderflash-t |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definite AF or Highly Probable AF
Definite AF or highly probable AF (adjudicated new AF lasting ≥2 minutes within 12 months of randomization)
Measured: 12 months
Secondary outcomes (10)
AF Lasting ≥2 Min or Death by 12 Months
Detection of atrial fibrillation lasting ≥ 2 minutes or death by 12 months.
Measured: 12 months
TIA
Transient ischemic attack.
Measured: 12 months
Recurrent Stroke
Recurrent ischemic stroke.
Measured: 12 months
Hemorrhage
Intracerebral hemorrhage.
Measured: 12 months
Death
Participant death.
Measured: 12 months
Oral Anticoagulation Therapy
Initiation of oral anticoagulation therapy in patients with definite AF.
Measured: 12 months
≥1 Serious Adverse Event
Patients with ≥1 serious adverse event.
Measured: 12 months
Compliance
Compliance with assigned therapy (accept ILR, conduct at least 80% of ELR assessments)
Measured: 12 months
Costs of Cardiac and Non-cardiac Investigations
Costs for all cardiac and non-cardiac investigations related to etiologic workup of index stroke / TIA.
Measured: 12 months
Duration of Any Detected Atrial Fibrillation / Atrial Flutter.
Total duration of any detected atrial fibrillation / atrial flutter.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, Alberta Innovates Health Solutions, Medtronic
- Responsible party
- Sponsor
- Investigators
- Brian H Buck, MD, MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428140
- Sponsor's protocol ID
- 00051629
- Acronym
- PERDIEM
- Status last verified
- Oct 2021
- First submitted
- 23 Apr 2015
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 34061146
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Embolic Rhythm Detection With Implantable Versus External Monitoring: Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT02428140
- Acronym / sponsor ID
- PERDIEM / 00051629
- Conditions
- Stroke, Atrial Fibrillation, Arrhythmias, Cardiac
- Keywords
- ischemic stroke, atrial fibrillation, etiologic investigations, secondary prevention, anticoagulation, arrhythmias, embolic stroke, undetermined etiology, implantable loop recorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Calgary, Alberta Innovates Health Solutions, Medtronic
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Recently completed randomized trials of cardiac monitoring following stroke have established that PAF is more common than previously recognized in cryptogenic stroke.
- The majority of TIA/stroke patients will have at least one potential stroke mechanism identified by the time etiologic investigations completed.
- 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.
- There are competing technologies for evaluating cardiac rhythm and diagnosing AF but no cost effectiveness data
- 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:
- 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.
- 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.
- What is the feasibility, patient compliance, diagnostic accuracy and rates of AF detection (>30 seconds) of ILR compared to the ELR strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implanted Loop Recorder | Experimental | Device: Medtronic Reveal LINQlong-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months |
| External Loop Recorder | Experimental | Device: Sorin Spiderflash-texternal event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Reveal LINQ | Device | Implanted Loop Recorder |
| Sorin Spiderflash-t | Device | External Loop Recorder |
Primary outcome
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)
10 secondary outcomes
AF Lasting ≥2 Min or Death by 12 Months
Time frame: 12 months
TIA
Time frame: 12 months
Recurrent Stroke
Time frame: 12 months
Hemorrhage
Time frame: 12 months
Death
Time frame: 12 months
Oral Anticoagulation Therapy
Time frame: 12 months
≥1 Serious Adverse Event
Time frame: 12 months
Compliance
Time frame: 12 months
Costs of Cardiac and Non-cardiac Investigations
Time frame: 12 months
Duration of Any Detected Atrial Fibrillation / Atrial Flutter.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34061146Buck 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.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian H Buck, MD, MSc principal investigator
University of Alberta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Reveal LINQ and Sorin Spiderflash-t in people with Stroke and Atrial Fibrillation, run by University of Alberta at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definite AF or Highly Probable AF (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02428140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.