Yield of Implantable Cardiac Monitoring Device in Patients With Acute Ischemic Stroke.

NCT05494034 | Recruiting

• 1 other identifier: ICM07082022
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective cohort study, the investigators aim to investigate the incidence of ICM-detected AF in unselected ischemic stroke patients and its association with anticoagulation initiation and stroke recurrence.

Conditions

Stroke, Acute; Stroke; Stroke, Ischemic; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Paroxysmal Atrial Fibrillation > 120 seconds

  the incidence of paroxysmal AF lasting 120 seconds or more in included patients evaluated with ICM.

  3 years

Secondary Outcomes (8)

• Paroxysmal Atrial Fibrillation > 6 minutes

  3 years

• anticoagulant initiation

  3 years

• recurrent ischemic strokes

  3 years

• subclinical infracts on follow-up MRI

  3 years

• major hemorrhagic events

  3 years

Study Arms (1)

implantable cardiac monitoring device ("Reveal LINQTM")

EXPERIMENTAL

All included patients will have long-term heart rate monitors (Reveal LINQ; Medtronic)

Device: Reveal LINQTM

Interventions

Reveal LINQTM DEVICE

implantable cardiac monitoring device ("Reveal LINQTM")

implantable cardiac monitoring device ("Reveal LINQTM")

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive acute ischemic stroke or TIA patients aged 40 years or older will be enrolled.
• Diagnosis of acute ischemic stroke will be based on clinical and neuroimaging evaluation \[brain computed tomography (CT) scan or magnetic resonance imaging (MRI) scan\].
• Stroke patients of all other etiologies (apart AF) presenting a HAVOC score ≥4 will be included in the study.
• Informed consent for participation in the study will be obtained from the patients or guardians of patients.

You may not qualify if:

• Patients with incomplete evaluation will be excluded, as previously described. \[22\] -Patients with known or newly detected AF at hospitalization will also be excluded.
• Not providing informed consent.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Second Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece

Athens, 12462, Greece

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chairman of Second Department of Neurology, School of Medicine, National & Kapodistrian University of Athens, "Attikon" University Hospital, Athens, Greece

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 9, 2022
• Study Start: May 5, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2030
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

GR (1)