Frequency and Size of In Situ Thrombus Within Patent Foramen Ovale.
Chaowu Yan, Hua Li, Cheng Wang...
https://pubmed.ncbi.nlm.nih.gov/36891906Actively Recruiting
Age: 18Years - 65Years
All Genders
ID06347276
De Novo Cerebral Microembolization Associated With Patent Foramen Ovale Closure
Led by China National Center for Cardiovascular Diseases · Updated on 2025-07-24
800
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
China National Center for Cardiovascular Diseases
Lead Sponsor
B
Beijing Anzhen Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study cerebral microembolization in patients undergoing transcatheter closure of patent foramen ovale (PFO) or atrial septal defect (ASD). It also investigates the link between new cerebral microembolization and in situ blood clots within the PFO. PFO is common and linked to conditions like ischemic stroke, transient ischemic attack, migraines, and embolization, with clot formation possibly playing a role in related stroke or migraine cases. Participants will receive transcatheter closure using PFO or ASD occluder devices. Before closure, brain diffusion-weighted MRI (DW-MRI) scans will be done, with additional DW-MRI scans at 24 hours and one month after the procedure. During PFO closure, right atrial angiography and optical coherence tomography (OCT) will assess the PFO structure and detect any clots while the patient performs the Valsalva maneuver. Throughout the study, patients will undergo brain imaging before and after closure to monitor cerebral microembolization and thrombus presence. Researchers will measure new cerebral microembolization occurring from 24 hours to 4 weeks after closure. The study includes detailed imaging and clot evaluations to better understand microembolization risks and outcomes following PFO or ASD closure, with participation lasting through at least one month post-procedure.
CONDITIONS
Brief Title
Cerebral Microembolization Associated With PFO Closure
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Documented PFO with medium-to-large shunts (≥ 20 microbubbles by c-TCD at rest or during Valsalva)
- History of embolic stroke or transient ischemic attack within 6 months without other causes
- History of migraine for more than one year without other causes
- Incidental PFO finding in asymptomatic individuals with high-risk activities or anatomical features
- Secundum ASD size 10 to 20 mm with sufficient surrounding rims except the aortic rim
- Right heart catheterization showing resting SPAP < 50 mm Hg, Qp/Qs ≥ 1.5, and PVR < 5 Wood units
You will not qualify if you...
- Known vascular risk factors including hypertension, high cholesterol, diabetes, atrial fibrillation, smoking, and obesity
- Embolic stroke or transient ischemic attack within the past one month
- History of deep vein thrombosis or pulmonary embolism
- Presence of coronary artery disease or carotid artery lesions
- Other cardiovascular structural malformations or diseases
- Allergy to contrast medium or nickel
- Refusal to participate
- Associated other cardiac abnormalities or diseases (for ASD group)
- Resting SPAP ≥ 50 mm Hg or PVR ≥ 5 Wood units
- Primum or sinus venosus type ASD
- Presence of intracardiac thrombi or permanent contraindications to platelet therapy
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants will be assessed for eligibility based on medical history and diagnostic criteria.
Implementation
Duration - Procedure day
Participants undergo transcatheter closure of patent foramen ovale (PFO) or atrial septal defect (ASD) with imaging and evaluation of cardiac structures during the procedure.
1 visit (in-person) for the closure procedure with right atrial angiography and OCT assessment.
Diagnostic Evaluation
Duration - 4 weeks
Participants undergo brain diffusion-weighted MRI (DW-MRI) scans before and after the closure procedure to detect cerebral microembolization and thrombus presence.
3 visits (in-person): 1 baseline DW-MRI before closure, 1 DW-MRI 24 hours after closure, and 1 DW-MRI 4 weeks after closure.
Trial Site Locations
Total: 1 location
1
Chaowu Yan
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
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Research Team
C
Chaowu Yan, PhD MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Preliminary Investigation of In situ Thrombus Within Patent Foramen Ovale in Patients With and Without Stroke.
Chaowu Yan, Hua Li
https://pubmed.ncbi.nlm.nih.gov/34032839