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

This study is currently recruiting participants.
Verified April 2012 by Medisch Spectrum Twente
Sponsor:
Information provided by (Responsible Party):
B. Oude Velthuis, Medisch Spectrum Twente
ClinicalTrials.gov Identifier:
NCT01550042
First received: March 7, 2012
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Medisch Spectrum Twente:

Primary Outcome Measures:
  • Documented Atrial Fibrillation (AF) [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time to documented AF using an Implantable Loop Recorder (ILR) data

  • Recurrent stroke [ Time Frame: One year ] [ Designated as safety issue: No ]
    Incidence of recurrent stroke


Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550042

Contacts
Contact: H Verheij +31534872105 h.verheij@mst.nl
Contact: B Oude Velthuis, MD MSc +31534872110 b.oudevelthuis@mst.nl

Locations
Netherlands
Medisch Spectrum Twente / Thoraxcenter Recruiting
Enschede, OV, Netherlands, NL7513ER
Contact: Harald Verheij     +31534872105     h.verheij@mst.nl    
Contact: Bob Oude Velthuis, MD MSc     +31534872110     b.oudevelthuis@mst.nl    
Principal Investigator: Bob Oude Velthuis, MD MSc            
Sponsors and Collaborators
Medisch Spectrum Twente
Investigators
Principal Investigator: Marcoen Scholten, MD PhD Medisch Spectrum Twente
  More Information

Additional Information:
Thoraxcenter  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: March 7, 2012
Last Updated: April 20, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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