Sweet spoT for cArdiac Rhythm monitorinG After sTrokE

NCT05717504 | Unknown

• 1 other identifier: 122103
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to compare the use of long-term vs. shorter-term heart monitoring to detect atrial fibrillation after stroke. Patients will be implanted with a loop recorder and will have study follow-up at 3-, 6- an 12-months after implantation. The investigators will evaluate 24 patients, between the 3 centers, in the same way the investigators plan to evaluate a larger number of participants (\>1000) in a future study. This will allow us to learn if such a study is possible, identify potential implementation challenges, and develop strategies to overcome those difficulties.

Conditions

Stroke; Atrial Fibrillation

Keywords

Implantable Loop Recorder; Anticoagulant; Stroke; Atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of patients enrolled at in 6 months

  Median and interquartile range recruitment rate. We will use this rate to estimate the number of sites and enrollment duration required for a larger RCT.

  6 months

Secondary Outcomes (9)

• Screened, declined and dropouts.

  2 years

• Number of clinical endpoint events per diagnostic arm

  2 years

• Quality of life survey analysis

  2 years

• AF timing of diagnosis

  2 years

• AF burden (1)

  2 years

Study Arms (2)

Disclosure

ACTIVE COMPARATOR

Group A (disclosure arm): patients and physicians will be informed about all AF episodes identified on ILR lasting for ≥6 minutes.

Device: Implantable Loop Recorder; Other: Quality of life survey

Non-Disclosure

ACTIVE COMPARATOR

Group B (non-disclosure arm): patients and physicians will be only informed about AF episodes identified on ILR lasting for ≥24h. This longer threshold is selected because of its association with increased risk of systemic embolism.

Device: Implantable Loop Recorder; Other: Quality of life survey

Interventions

Implantable Loop Recorder DEVICE

Patients will be implanted with a loop recorder. Patients will be given the choice of remove the loop recorder after the 12-months follow-up visit or at the end of its battery life (approximately 3 years)

Disclosure; Non-Disclosure

Quality of life survey OTHER

A quality of life survey will be performed at the end of the follow-up period. The survey will be done over the phone or in person if the follow-up visit is in person.

Disclosure; Non-Disclosure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult patients with cortical or subcortical, cryptogenic or non-cryptogenic acute ischemic stroke

You may not qualify if:

• AF on 24-h inpatient or Holter monitoring
• Atrial or ventricular thrombus
• Other major-risk cardioembolic sources (e.g., mechanical valve)
• Other indications (e.g., venous thromboembolism) or contraindications for OACs.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Heart and Stroke Foundation of Canada: collaborator

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luciano A Sposato, MD, MBA

  LHSC - Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Ayan, MSc.

CONTACT

519-685-8500; diana.ayan@lhsc.on.ca

Jennifer Moussa

CONTACT

519-685-8500; jennifer.moussa@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 8, 2023
• Study Start: November 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: February 1, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10