NCT04686253 Internal Microstructure of Patent Foramen Ovale Related to Stroke
| NCT ID | NCT04686253 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Patent Foramen Ovale |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2020-12-23 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2020-12-23 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04686253 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 65 Years, studying Patent Foramen Ovale. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04686253 currently recruiting?
Yes, NCT04686253 is actively recruiting participants. Contact the research team at chaowuyan@163.com for enrollment information.
Where is the NCT04686253 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT04686253 clinical trial?
NCT04686253 is sponsored by China National Center for Cardiovascular Diseases. The trial plans to enroll 1,200 participants.