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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01025947

Acronym

CRYPTONITE

Enrollment

100

Registered

2009-12-04

Start date

2009-03-01

Completion date

2013-03-01

Last updated

2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke

Keywords

Atrial fibrillation, Cryptogenic stroke, Implantable loop recorder

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Spain

Contacts

PRINCIPAL_INVESTIGATORRicardo Ruiz-Granell, MD, Phd

Hospital Clinico Universitario de Valencia

STUDY_CHAIRArcadio Garcia-Alberola, MD, PhD

Hospital Universitario Virgen de la Arrixaca

STUDY_CHAIRAna Morales, MD