Examines a heart opening in people with stroke or migraine
Studies a heart opening, patent foramen ovale, in people with stroke or migraine.
Plain-language title generated from the registry record
Registry title: Internal Microstructure of Patent Foramen Ovale Related to Stroke
Key facts
- Where
- Beijing, ChinaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 65 years old?
Source: NCT04686253, who can take part
Where in China
- Chaowu YanBeijing, ChinaTaking people
- National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- China National Center for Cardiovascular Diseases
- Trial code
- NCT04686253
- Record updated
- 22 July 2025
- Original description
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.Read full original descriptionShow less
Internal Microstructure of Patent Foramen Ovale Related to Cryptogenic Stroke, Transient Ischemic Attack or Migraine
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.
Inclusion: 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 c-TCD; Stroke group: history of ischemic stroke (based on brain magnetic resonance imaging) or TIA within 6 months without other identifiable causes (Phase1); Migraine group: history of migraine headaches more than one year without other identifiable causes (Phase2); Control group: incidental finding of PFO without neurological or systemic symptoms (Phase3).
Exclusion: 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/diseases; Presence of carotid artery lesions or coronary artery disease; Presence of deep vein thrombosis or pulmonary embolism; Presence of implanted cardiac devices; Allergic to contrast medium; Echocardiographic evidence of intra-cardiac thrombus, mass, tumor or vegetation; Active endocarditis or other infections; Evidence of hypercoagulable state.