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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
B. Oude Velthuis, Medisch Spectrum Twente Identifier:
First received: March 7, 2012
Last updated: July 6, 2016
Last verified: July 2016
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.

Atrial Fibrillation

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 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

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)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
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Please refer to this study by its identifier: NCT01550042

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

Responsible Party: B. Oude Velthuis, Research fellow electrophysiology, Medisch Spectrum Twente Identifier: NCT01550042     History of Changes
Other Study ID Numbers: NL36491.044.11  P11-25 
Study First Received: March 7, 2012
Last Updated: July 6, 2016
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes processed this record on October 27, 2016