Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients

Terminated

• Conditions: Atrial Fibrillation; Stroke

• Registration Number: NCT01550042
• Lead Sponsor: Medisch Spectrum Twente

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-09
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Documented Atrial Fibrillation (AF)	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

Name	Time	Method
Time to documented AF	One year	Time to documented AF using an Implantable Loop Recorder (ILR) data
Recurrent stroke	One year	Incidence of recurrent stroke

Trial Locations

Locations (1)

Medisch Spectrum Twente / Thoraxcenter; 🇳🇱 Enschede, OV, Netherlands