Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients

Stroke Clinical Trial

— SCARF  

Official title:

Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01550042
• Other study ID #: NL36491.044.11
• Secondary ID: P11-25
• Status: Active, not recruiting
• Phase: N/A
• First received: March 7, 2012
• Last updated: July 6, 2016
• Start date: September 2011
• Est. completion date: April 2017

Study information

• Verified date: July 2016
• Source: Medisch Spectrum Twente
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twente / Thoraxcenter	Enschede	OV

Sponsors (1)

Lead Sponsor	Collaborator
Medisch Spectrum Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documented Atrial Fibrillation (AF)	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.	One year	No
Secondary	Time to documented AF	Time to documented AF using an Implantable Loop Recorder (ILR) data	One year	No
Secondary	Recurrent stroke	Incidence of recurrent stroke	One year	No