Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients

NCT ID: NCT01550042

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-04-30

Brief Summary

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Recent studies demonstrated that prolonged rhythm observation increases the detection of atrial fibrillation in patients prior diagnosed as cryptogenic stroke. Detection of atrial fibrillation in these patients has important therapeutic implications for the anticoagulation regimen. However, data on optimal monitoring duration and method of AF detection are limited.

Detailed Description

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Conditions

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Atrial Fibrillation Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intensive observation cohort

Patients \> 18 years of age diagnosed with a recent episode of cryptogenic stroke with long term rhythm observation using an implantable loop recorder for detecting atrial fibrillation.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients \> 18 years of age Recent episode (≤60 days) of cryptogenic ischemic stroke
* Undetermined etiology with negative evaluation (including cardioembolism work- up) according to the criteria for the Trial of Org 10172 in Acute Stroke Treatment (TOAST)
* Implantation of an implantable loop recorder within two months after index event
* Able of providing informed consent

Exclusion Criteria

* Pre-existing indication for vitamin K antagonist
* Untreated hyperthyroidism
* Indication for pacemaker implantation, implantable cardioverter defibrillator (ICD) or Cardiac Resynchronisation Therapy (CRT)
* Severe co-morbidity not likely to complete follow-up for one year
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medisch Spectrum Twente

OTHER

Sponsor Role lead

Responsible Party

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B. Oude Velthuis

Research fellow electrophysiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcoen Scholten, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Medisch Spectrum Twente

Locations

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Medisch Spectrum Twente / Thoraxcenter

Enschede, Overijssel, Netherlands

Site Status

Countries

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Netherlands

Related Links

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Other Identifiers

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P11-25

Identifier Type: OTHER

Identifier Source: secondary_id

NL36491.044.11

Identifier Type: -

Identifier Source: org_study_id

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