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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Valencia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hospital Universitario Virgen de la Arrixaca
Universidad de Murcia
Information provided by:
University of Valencia
ClinicalTrials.gov Identifier:
NCT01025947
First received: December 3, 2009
Last updated: June 25, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition
Atrial Fibrillation
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Valencia:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All subsequent AF episodes detected by the ILR after primary outcome (AF burden) [ Time Frame: Patients will be followed up during two years ] [ Designated as safety issue: No ]
  • AF episodes detected by external monitoring [ Time Frame: Patients will be followed up during two years ] [ Designated as safety issue: No ]
  • Presence of stroke, recurrent TIA, or silent infarction in neuroimaging [ Time Frame: Patients will be followed up during two years ] [ Designated as safety issue: No ]
  • Changes in anticoagulant therapy [ Time Frame: Patients will be followed up during two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study group
Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted

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

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025947

Contacts
Contact: Ricardo Ruiz-Granell, MD, PhD 0034 963862658 ruiz_ric@gva.es
Contact: Arcadio García-Alberola, MD, PhD arcadi@secardiologia.es

Locations
Spain
Hospital Universitario Virgen de la Arrixaca Recruiting
Murcia, Spain, 30120
Principal Investigator: Arcadio García-Alberola, MD, PhD            
Principal Investigator: Ana Morales, MD            
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Principal Investigator: Ricardo Ruiz-Granell, MD, PhD            
Principal Investigator: Alejandro Ponz, MD            
Sponsors and Collaborators
University of Valencia
Hospital Universitario Virgen de la Arrixaca
Universidad de Murcia
Investigators
Principal Investigator: Ricardo Ruiz-Granell, MD, Phd Hospital Clinico Universitario de Valencia
Study Chair: Arcadio Garcia-Alberola, MD, PhD Hospital Universitario Virgen de la Arrixaca
Study Chair: Ana Morales, MD Hospital Universitario Virgen de la Arrixaca
Study Chair: Alejandro Ponz, MD Hospital Clinico Universitario de Valencia
  More Information

Publications:

Responsible Party: Ricardo Ruiz Granell, MD, PhD, Hospital Clínico Universitario de Valencia
ClinicalTrials.gov Identifier: NCT01025947     History of Changes
Other Study ID Numbers: HCUV
Study First Received: December 3, 2009
Last Updated: June 25, 2010
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by University of Valencia:
Atrial fibrillation
Cryptogenic stroke
Implantable loop recorder

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Cerebral Infarction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2013