"Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder (ILR)"

• Conditions: Atrial Fibrillation; Stroke

• Registration Number: NCT01025947
• Lead Sponsor: University of Valencia

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

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-25
• Last Update Posted: 2010-06-28
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)
  • Acceptance and signature of Patient Informed Consent.

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
  • Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Hospital Clinico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain