Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke
Subtle Ultrasound Atrial Anomalies Predicts the Early Diagnosis of Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Patients With Cryptogenic Stroke. A Randomized Trial
Parc de Salut Mar
100 participants
Jan 1, 2021
INTERVENTIONAL
Conditions
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 use of implantable cardiac monitors (ICM) early after the CS has demonstrated benefits in the diagnostic yield, but the indication for ICM in the current guidelines remains unclear. Atrial contraction strain (ACS) evaluated by cardiac ultrasound could be of help to select the patients more prone to suffer from silent PAF. The purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS. Clinical and ultrasound predictors of PAF occurrence (ACS) will be studied in order to define patients needing a closer follow-up.
Eligibility
Inclusion Criteria6
- 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 Criteria6
- 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).
Interventions
ICM implant 3-4 days after the stroke and prior to discharge. All devices (Abbott Confirm or Jot) were implanted subcutaneously under local anaesthesia in the left chest region and programmed with an specific algorithm for AF detection set at 30 seconds for detection. All patients were included in remote monitoring system (Merlin), which was programmed to send alerts in case of registering episodes qualifying for AF detection, and a monthly routine registration. All ICM recordings were reviewed by a specialized cardiologist.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06542770