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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Medisch Spectrum Twente.
Recruitment status was  Recruiting
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

March 7, 2012
April 20, 2012
September 2011
September 2012   (final data collection date for primary outcome measure)
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.
Documented 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.
Complete list of historical versions of study NCT01550042 on ClinicalTrials.gov Archive Site
  • 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
  • Time to documented AF [ Time Frame: One year ] [ Designated as safety issue: No ]
    Time to documented AF using ILR data
  • Recurrent stroke [ Time Frame: One year ] [ Designated as safety issue: No ]
    Incidence of recurrent stroke
Not Provided
Not Provided
 
Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients
Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients admitted with a ischemic stroke of undetermined etiology

  • Atrial Fibrillation
  • Stroke
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
September 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: H Verheij +31534872105 h.verheij@mst.nl
Contact: B Oude Velthuis, MD MSc +31534872110 b.oudevelthuis@mst.nl
Netherlands
 
NCT01550042
NL36491.044.11, P11-25
Yes
B. Oude Velthuis, Medisch Spectrum Twente
Medisch Spectrum Twente
Not Provided
Principal Investigator: Marcoen Scholten, MD PhD Medisch Spectrum Twente
Medisch Spectrum Twente
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP