This trial is active, not recruiting.

Conditions atrial fibrillation, stroke
Sponsor Medisch Spectrum Twente
Start date September 2011
End date April 2015
Trial size 50 participants
Trial identifier NCT01550042, NL36491.044.11, P11-25


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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.

Primary Outcomes

Documented Atrial Fibrillation (AF)
time frame: One year

Secondary Outcomes

Time to documented AF
time frame: One year
Recurrent stroke
time frame: One year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients
Principal investigator Marcoen Scholten, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Medisch Spectrum Twente.