Observational Study on Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder

University of Valencia2 sites in 1 country100 target enrollmentMarch 2009

ConditionsAtrial Fibrillation Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: University of Valencia
Enrollment: 100
Locations: 2
Primary Endpoint: First AF episode detected by the implantable loop recorder in patients that had a cryptogenic stroke. An AF episode will be considered an AF episode that lasts at least 2 minutes.
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

STUDY TYPE:

Prospective, national , multicenter, and observational study.

OBJECTIVE:

To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF detection device during a period of 2 years.

DEVICE:

Reveal XT 9529 (SQDM)

SAMPLE SIZE AND STUDY DURATION:

100 patients enrolled which will be followed during a period of 2 years.

Detailed Description

Observational study in patients with cryptogenic stroke (TOAST criteria) and with an implanted EKG loop recorder, with the primary objective of knowing the atrial fibrillation incidence in this population

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

March 2013

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Valencia

Eligibility Criteria

Inclusion Criteria

•All patients included must meet one of these two conditions:
•Patient presenting with an episode of transient ischemic attack (TIA) of cryptogenic origin with neurological symptoms of less than 24h of evolution and negative neuroimaging.
•First episode of ischaemic stroke with cryptogenic etiology following TOAST criteria
•All patients must meet all of the following:
•The patient has been implanted an ILR within 30 days after qualifying event
•Age between 45-85 years
•No stenosis \>50% in any arterial vessel corresponding to the affected territory
•Normal Echocardiography
•Normal 24 hours EKG Holter recording
•Absence of Patent Foramen Ovale through transcranial doppler (or transesophageal echocardiography)

Exclusion Criteria

•All patients included cannot meet any of the following conditions:
•Recurrent stroke or TIA
•Stroke or TIA with determined etiology according to TOAST criteria.
•Anticoagulation indication at the time of enrollment in the study.
•Total contraindication for anticoagulation therapy
•Atrial fibrillation detection prior to enrollment
•Severe cognitive impairment or dementia
•Patient unable to be followed up
•Patients enrolled in another clinical trial
•Patients with life expectancy of less than 1 year

Outcomes

Primary Outcomes

First AF episode detected by the implantable loop recorder in patients that had a cryptogenic stroke. An AF episode will be considered an AF episode that lasts at least 2 minutes.

Time Frame: Patients will be followed up during two years, regardless of reaching or not the primary endpoint.

Secondary Outcomes

All subsequent AF episodes detected by the ILR after primary outcome (AF burden)(Patients will be followed up during two years)
AF episodes detected by external monitoring(Patients will be followed up during two years)
Presence of stroke, recurrent TIA, or silent infarction in neuroimaging(Patients will be followed up during two years)
Changes in anticoagulant therapy(Patients will be followed up during two years)