Actively Recruiting
Internal Microstructure of Patent Foramen Ovale Related to Stroke
Led by China National Center for Cardiovascular Diseases · Updated on 2025-07-22
1200
Participants Needed
2
Research Sites
418 weeks
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 study aims to (1) investigate the internal microstructure of patent foramen ovale related to cryptogenic stroke, transient ischemic attack or migraine and determine the effectiveness of transcatheter closure in these patients; (2) evaluate the microstructural features of asymptomatic patients with PFO and make a follow-up；(3) perform an untargeted metabolomics analysis using plasma samples from right atrium and left atrium and shunt provocative test was conducted;(4) collect the blood sample from PFO tunnel;(5) cardiac CTA was performed to evaluate the position and morphology of device.
CONDITIONS
Official Title
Internal Microstructure of Patent Foramen Ovale Related to Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 16 to 65 years without any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity
- Documented PFO with right-to-left shunt 20 micro-bubbles by contrast transcranial Doppler (c-TCD)
- Stroke group: history of ischemic stroke or TIA within 6 months without other identifiable causes
- Migraine group: history of migraine headaches for 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, TIA, or migraine other than PFO
- History of stroke or TIA within the past one month
- Presence of cardiac enlargement or dysfunction
- Presence of coexisting 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
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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
Research Team
C
Chaowu Yan, PhD and MD
CONTACT
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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