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: 16Years - 65Years
All Genders
ID04686253
Internal Microstructure of Patent Foramen Ovale Related to Cryptogenic Stroke, Transient Ischemic Attack or Migraine
Led by China National Center for Cardiovascular Diseases · Updated on 2025-07-22
1200
Participants Needed
2
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
Researchers are studying the internal structure of patent foramen ovale (PFO), a heart condition linked to cryptogenic stroke, transient ischemic attack (TIA), and migraine. The study aims to understand how the microstructure of PFO relates to these conditions and to assess the effectiveness of closing the PFO with a catheter-based procedure. It also includes examining asymptomatic PFO patients and analyzing blood samples to explore related metabolic features. The study includes three groups: patients with PFO who have had a stroke or TIA and undergo closure, patients with PFO and migraine who also undergo closure, and asymptomatic patients with PFO who are followed for five years without closure. Blood samples are collected from various heart and vessel sites, and cardiac CT angiography (CTA) is used to evaluate device placement and shape. Participants will be monitored through clinical evaluations and blood tests, including metabolomics analysis from the right and left atrium. Researchers record symptoms during a test where blood is transferred between heart chambers. The main outcome measured is adverse events over five years after assessing the PFO's internal microstructure. This helps understand risks and guide treatment decisions for PFO-related conditions.
CONDITIONS
Brief Title
Internal Microstructure of Patent Foramen Ovale Related to Stroke
Who Can Participate
Age: 16Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 16 to 65 years without any known vascular risk factors such as hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking, and obesity
- Documented patent foramen ovale (PFO) with right-to-left shunt of at least 20 micro-bubbles by contrast transcranial Doppler
- Stroke group: history of ischemic stroke or transient ischemic attack within 6 months without other identifiable causes
- Migraine group: history of migraine headaches lasting more than one year without other identifiable causes
- Control group: incidental finding of PFO without neurological or systemic symptoms
You will not qualify if you...
- Any identifiable cause of ischemic stroke, transient ischemic attack, or migraine other than PFO
- History of stroke or transient ischemic attack within the past one month
- Presence of cardiac enlargement or dysfunction
- Presence of other cardiovascular structural malformations or diseases
- Presence of carotid artery lesions or coronary artery disease
- Presence of deep vein thrombosis or pulmonary embolism
- Presence of implanted cardiac devices
- Evidence of hypercoagulable state
- Allergy to contrast medium
- Echocardiographic evidence of intra-cardiac thrombus, mass, tumor, or vegetation
- Active endocarditis or other infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Initial evaluation period
Participants undergo diagnostic evaluations including blood sample collection from multiple heart and vessel sites, shunt provocative testing with symptom monitoring, and cardiac CTA to assess the position and morphology of PFO and any device.
1 to 3 visits depending on cohort assignment
Treatment
Duration - Treatment duration as per procedure
Participants in the stroke and migraine groups receive transcatheter closure of PFO.
1 procedure visit
Long-term Monitoring
Duration - 5 years
Participants without symptoms undergo follow-up over 5 years to monitor for outcomes related to PFO without active intervention.
Periodic follow-up visits over 5 years
Trial Site Locations
Total: 2 locations
1
Chaowu Yan
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
2
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
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Research Team
C
Chaowu Yan, PhD and 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
3
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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