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

June 25, 2010 updated by: University of Valencia

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ricardo Ruiz-Granell, MD, PhD
  • Phone Number: 0034 963862658
  • Email: ruiz_ric@gva.es

Study Contact Backup

Study Locations

  • Spain
      • Murcia, Spain, 30120
        • Recruiting
        • Hospital Universitario Virgen de la Arrixaca
        • Principal Investigator:
          • Arcadio García-Alberola, MD, PhD
        • Principal Investigator:
          • Ana Morales, MD
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Principal Investigator:
          • Ricardo Ruiz-Granell, MD, PhD
        • Principal Investigator:
          • Alejandro Ponz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Study group
Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome 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.
Time Frame: Patients will be followed up during two years, regardless of reaching or not the primary endpoint.
Patients will be followed up during two years, regardless of reaching or not the primary endpoint.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
All subsequent AF episodes detected by the ILR after primary outcome (AF burden)
Time Frame: Patients will be followed up during two years
Patients will be followed up during two years
AF episodes detected by external monitoring
Time Frame: Patients will be followed up during two years
Patients will be followed up during two years
Presence of stroke, recurrent TIA, or silent infarction in neuroimaging
Time Frame: Patients will be followed up during two years
Patients will be followed up during two years
Changes in anticoagulant therapy
Time Frame: Patients will be followed up during two years
Patients will be followed up during two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valencia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad de Murcia
Hospital Universitario Virgen de la Arrixaca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HCUV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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