Clinical trial NCT01025947: "Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder (ILR)"
Official title: Observational Study on Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Stroke
Keywords: Atrial fibrillation
Cryptogenic stroke
Implantable loop recorder
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Virgen de la Arrixaca
name: Universidad de Murcia
First posted: 2009-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted for detection of atrial fibrillation

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

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)
  * 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

Primary outcomes:
measure: 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.
timeFrame: Patients will be followed up during two years, regardless of reaching or not the primary endpoint.
Secondary outcomes:
measure: All subsequent AF episodes detected by the ILR after primary outcome (AF burden)
timeFrame: Patients will be followed up during two years
measure: AF episodes detected by external monitoring
timeFrame: Patients will be followed up during two years
measure: Presence of stroke, recurrent TIA, or silent infarction in neuroimaging
timeFrame: Patients will be followed up during two years
measure: Changes in anticoagulant therapy
timeFrame: Patients will be followed up during two years
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
Study officials:
affiliation: Hospital Clinico Universitario de Valencia
name: Ricardo Ruiz-Granell, MD, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Arcadio Garcia-Alberola, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Ana Morales, MD
role: STUDY_CHAIR
affiliation: Hospital Clinico Universitario de Valencia
name: Alejandro Ponz, MD
role: STUDY_CHAIR
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