NCT04686253Recruiting
Internal Microstructure of Patent Foramen Ovale Related to Stroke
Internal Microstructure of Patent Foramen Ovale Related to Cryptogenic Stroke, Transient Ischemic Attack or Migraine
Source: ClinicalTrials.gov · Last updated 22 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1200 (estimated)
- First submitted
- 23 Dec 2020
- Start date
- 23 Dec 2020
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- China National Center for Cardiovascular Diseases
- NCT number
- NCT04686253
What you commit to
- Study type: Observational
- Planned participants: 1200
- From 23 Dec 2020 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Evidence of hypercoagulable state;
Who the study is looking for
- 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).
Age in the registry: 16 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Chaowu Yan Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
Related publications
- Association of incomplete device apposition with stroke recurrence after patent foramen ovale closure.Heart · 2026 · PMID 42567695
This page is information, not medical advice. Discuss any trial with your doctor.