NCT06347276 Cerebral Microembolization Associated With PFO Closure
| NCT ID | NCT06347276 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Thrombosis Cardiac |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-12-31 |
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 800 participants in total. It began in 2024-01-01 with a primary completion date of 2026-12-31.
⚠ 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 investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within PFO.
Eligibility Criteria
PFO group Inclusion Criteria: 1\) age 18 to 65 years; 2) documented PFO with medium-to-large shunts (≥ 20 microbubbles by c-TCD at rest or during the Valsalva maneuver); 3) history of embolic stroke (based on brain magnetic resonance imaging within 24 hours after symptom onset) or TIA within 6 months without other identifiable causes; 4) history of migraine for more than one year without other identifiable causes; 5) asymptomatic group: incidental finding of PFO in asymptomatic individuals, and presence of high-risk activities and/or anatomical features related to PFO (high-risk activities were defined as those in which the Valsalva maneuver was performed frequently or those that increased the risk of venous gas formation; and high-risk anatomical features included atrial septal aneurysm and/or curtain pattern on c-TCD). Exclusion Criteria: 1\) presence of any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity; 2) history of embolic stroke or TIA within the past one month; 3) history of deep vein thrombosis or pulmonary embolism; 4) presence of coronary artery disease and carotid artery lesions; 5) presence of coexistent cardiovascular structural malformations or diseases; 6) allergy to contrast medium; 7) refusal to participate. ASD group Inclusion Criteria: 1\) age 18 to 65 years; 2) secundum ASD size 10 to 20 mm, with sufficient surrounding rims, except the aortic rim; 3) right heart catheterization: resting SPAP \< 50 mm Hg, Qp/Qs ≥ 1.5 and PVR \< 5 WU. Exclusion Criteria: 1\) presence of any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity; 2) associated with other cardiac abnormalities or diseases; 3) resting SPAP ≥50 mm Hg and resting PVR ≥5 Wood units;4) primum or sinus venosus type ASD; 5) presence of intracardiac thrombi, permanent contraindications to platelet therapy, and allergic reaction to nickel.
Contact & Investigator
Chaowu Yan, PhD MD
PRINCIPAL INVESTIGATOR
Cardiovascular Institute and Fuwai Hospital
Frequently Asked Questions
Who can join the NCT06347276 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Thrombosis Cardiac. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06347276 currently recruiting?
Yes, NCT06347276 is actively recruiting participants. Contact the research team at chaowuyan@163.com for enrollment information.
Where is the NCT06347276 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06347276 clinical trial?
NCT06347276 is sponsored by China National Center for Cardiovascular Diseases. The principal investigator is Chaowu Yan, PhD MD at Cardiovascular Institute and Fuwai Hospital. The trial plans to enroll 800 participants.