Status:
RECRUITING
Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke
Lead Sponsor:
Parc de Salut Mar
Conditions:
Paroxysmal Atrial Fibrillation
Cardiac Rhythm Disorder
Eligibility:
All Genders
50-89 years
Phase:
NA
Brief Summary
Cryptogenic stroke (CS) causes about 30% of admissions to a stroke unit. Silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of patients. The...
Detailed Description
Introduction Cryptogenic stroke (CS) is a stroke in which etiology cannot be determined after a comprehensive evaluation and it is the cause of about 30% of admissions to a stroke unit. In these case...
Eligibility Criteria
Inclusion
- Acute ischemic stroke or transient ischemic attack (TIA) from January 2022 to July 2023
- Age between 50 and 89 years;
- Undetermined origin at hospital admission according to the SSS-TOAST criteria (2):
- Absence of major structural heart disease by cardiac ultrasound (normal global and segmental left ventricle contraction, absence of valvular/rheumatic disease, absence of intracardiac shunts)
- Absence of AF during 48h ECG-monitoring
- Absence of major anomalies in the supra-aortic trunks ultrasound.
Exclusion
- Patients with a history of hemorrhagic stroke;
- Presence with prior atrial fibrillation or atrial flutter;
- Permanent contraindication or indication for OAC for other reasons;
- Recent (\<1 month) major surgery or cardiac events;
- Presence of severe cardiac abnormalities;
- Patients with life expectancy \<1 year or severe stroke (modified Rankin Scale \> 4).
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06542770
Start Date
January 1 2021
End Date
December 1 2024
Last Update
August 7 2024
Active Locations (1)
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1
Hospital del Mar
Barcelona, Spain, 08003