Predicting Atrial Fibrillation with High Risk of Embolization with Atrial Strain and NT-proBNP.
Jorge Pagola, Jesus Juega, Jaume Francisco-Pascual...
https://pubmed.ncbi.nlm.nih.gov/33184686/Actively Recruiting
Led by Parc de Salut Mar · Updated on 2024-08-07
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
Cryptogenic stroke CS causes about 30% of stroke unit admissions and often has an unknown cause. Silent paroxysmal atrial fibrillation PAF is believed to underlie many CS cases. This study evaluates the usefulness of implantable cardiac monitors ICM for early detection of silent PAF in patients with CS. The study also explores clinical and ultrasound predictors, such as atrial contraction strain ACS, to identify patients at higher risk who may need closer monitoring. Patients admitted with CS are randomized within 48 hours of admission to either standard care or early ICM implantation before discharge. The ICM devices are implanted subcutaneously in the chest and programmed to detect atrial fibrillation episodes lasting 30 seconds or more. The study also uses cardiac ultrasound to assess atrial features like left atrial volume and strain to classify patients as having atrial cardiomyopathy or not. Standard care includes continuous ECG monitoring for at least 48 hours and follow-up ECGs and Holter monitoring. Participants undergo neurological exams, ECGs, brain imaging, and blood tests during admission and are followed up in outpatient clinics at 3, 6, 12 months, and every 6 months thereafter up to 2 years. Researchers will monitor for atrial fibrillation detection confirmed by ECG or device recordings, assess ultrasound predictors of PAF, and track stroke recurrence. All ICM recordings are reviewed by specialists, and oral anticoagulation is started if atrial fibrillation is detected.
CONDITIONS
Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke
E
Ermengol Valles Gras, PhD
A
Ana Beatriz Garcia Duran, MD
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Parc de Salut Mar
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days after stroke
Participants undergo comprehensive evaluations including cardiac ultrasound to identify atrial cardiomyopathy and baseline assessments before randomization.
1 visit (in-person) before randomization
Duration - Up to 2 years
Participants randomized to the intervention group receive an implantable cardiac monitor (ICM) 3-4 days after stroke before discharge, with remote monitoring for atrial fibrillation detection.
ICM implantation visit plus monthly remote monitoring and outpatient visits at 3, 6, 12 months and every 6 months thereafter
Duration - Up to 2 years
Participants in the control group receive standard care with serial ECGs during hospital stay and outpatient ECGs plus 72-hour Holter monitoring to detect atrial fibrillation.
Daily ECGs during hospital stay, outpatient ECGs at 3, 6, 12 months and every 6 months thereafter, and 1 scheduled 72-hour Holter monitoring
Duration - Up to 2 years
All participants are followed for up to 2 years to detect atrial fibrillation and stroke recurrence through scheduled visits and monitoring.
Outpatient visits at 3, 6, 12 months and every 6 months thereafter
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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https://pubmed.ncbi.nlm.nih.gov/29054732/Parc de Salut Mar
Lead Sponsor