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

University of Valencia

Status: Unknown

Conditions: Atrial Fibrillation; Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT01025947

HCUV

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Study group

Description:

Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted