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Clinical Trials in China / NCT04686253
Recruiting Observational

Internal Microstructure of Patent Foramen Ovale Related to Stroke

NCT04686253 · tracked via the Priya Life Science China tracker
Sponsor
China National Center for Cardiovascular Diseases
Phase
Observational
Started
2020-12-23
Last updated
2025-07-22

Condition(s) studied

Patent Foramen Ovale

Investigational drug(s) / intervention(s)

not appliable

not appliable: not appliable

Study summary

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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients aged 16 to 65 years without any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity; 2. Documented PFO with right-to-left shunt ≥ 20 micro-bubbles by c-TCD; 3. Stroke group: history of ischemic stroke (based on brain magnetic resonance imaging) or TIA within 6 months without other identifiable causes (Phase1); 4. Migraine group: history of migraine headaches more than one year without other identifiable causes (Phase2); 5. Control group: incidental finding of PFO without neurological or systemic symptoms (Phase3). Exclusion Criteria: 1. Any identifiable cause of ischemic stroke/TIA or migraine other than PFO; 2. History of stroke or TIA within the past one month; 3. Presence of cardiac enlargement or dysfunction; 4. Presence of coexisting cardiovascular structural malformations/diseases; 5. Presence of carotid artery lesions or coronary artery disease; 6. Presence of deep vein thrombosis or pulmonary embolism; 7. Presence of implanted cardiac devices; 8. Evidence of hypercoagulable state; 9. Allergic to contrast medium; 10. Echocardiographic evidence of intra-cardiac thrombus, mass, tumor or vegetation; 11. Active endocarditis or other infections.

Primary outcome measure(s)

  • Adverse Events after evaluation of PFO internal microstructure — 5 years
    cryptogenic stroke, transient ischemic attack , migraine or systemic embolism

Trial sites (2)

FacilityCityRegionStatus
Chaowu Yan Beijing Beijing Municipality Recruiting
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital Beijing Beijing Municipality Recruiting

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Other trials for the same condition

Establishment of a Clinical and Prognostic Follow-up Cohort of Migraine Patients With Patent Foramen Ovale Recruiting
Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine Recruiting
Study on the Safety and Effectiveness of the SnowyTM PFO Closure System Starting soon
Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04686253 on ClinicalTrials.gov ↗ ← All trials in China