Post-Embolic Rhythm Detection With Implantable Versus External Monitoring

Stroke Clinical Trial

— PERDIEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428140
• Other study ID #: 00051629
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2019

Study information

• Verified date: October 2021
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Stroke

Intervention

Device:
• Medtronic Reveal LINQ

• Sorin Spiderflash-t

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Grey Nuns Community Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Alberta	Alberta Innovates Health Solutions, Medtronic, University of Calgary

Country where clinical trial is conducted

Canada, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Predictors of AF Detection	Association between baseline clinical characteristics (e.g. comorbidities, burden of supraventricular ectopy on Holter, left atrial dimension) and subsequent detection of AF	12 months
Primary	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	AF Lasting =2 Min or Death by 12 Months	Detection of atrial fibrillation lasting = 2 minutes or death by 12 months.	12 months
Secondary	TIA	Transient ischemic attack.	12 months
Secondary	Recurrent Stroke	Recurrent ischemic stroke.	12 months
Secondary	Hemorrhage	Intracerebral hemorrhage.	12 months
Secondary	Death	Participant death.	12 months
Secondary	Oral Anticoagulation Therapy	Initiation of oral anticoagulation therapy in patients with definite AF.	12 months
Secondary	=1 Serious Adverse Event	Patients with =1 serious adverse event.	12 months
Secondary	Compliance	Compliance with assigned therapy (accept ILR, conduct at least 80% of ELR assessments)	12 months
Secondary	Costs of Cardiac and Non-cardiac Investigations	Costs for all cardiac and non-cardiac investigations related to etiologic workup of index stroke / TIA.	12 months
Secondary	Duration of Any Detected Atrial Fibrillation / Atrial Flutter.	Total duration of any detected atrial fibrillation / atrial flutter.	12 months

External Links

•   Final Publication