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Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients (SCARF)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550042
First Posted: March 9, 2012
Last Update Posted: July 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
B. Oude Velthuis, Medisch Spectrum Twente
  Purpose
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.

Condition
Atrial Fibrillation Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients

Resource links provided by NLM:


Further study details as provided by B. Oude Velthuis, Medisch Spectrum Twente:

Primary Outcome Measures:
  • Documented Atrial Fibrillation (AF) [ Time Frame: One year ]
    The percentage of patients with documented AF based on implantable cardiac monitor registration during a follow-up period of at least 12 months after an episode of cryptogenic stroke.


Secondary Outcome Measures:
  • Time to documented AF [ Time Frame: One year ]
    Time to documented AF using an Implantable Loop Recorder (ILR) data

  • Recurrent stroke [ Time Frame: One year ]
    Incidence of recurrent stroke


Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: April 2017
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted with a ischemic stroke of undetermined etiology
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550042


Locations
Netherlands
Medisch Spectrum Twente / Thoraxcenter
Enschede, OV, Netherlands, NL7513ER
Sponsors and Collaborators
Medisch Spectrum Twente
Investigators
Principal Investigator: Marcoen Scholten, MD PhD Medisch Spectrum Twente
  More Information

Additional Information:
Responsible Party: B. Oude Velthuis, Research fellow electrophysiology, Medisch Spectrum Twente
ClinicalTrials.gov Identifier: NCT01550042     History of Changes
Other Study ID Numbers: NL36491.044.11
P11-25 ( Other Identifier: METC Twente )
First Submitted: March 7, 2012
First Posted: March 9, 2012
Last Update Posted: July 7, 2016
Last Verified: July 2016

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


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