Internal Microstructure of Patent Foramen Ovale Related to Stroke
IMPORT
1 other identifier
observational
1,200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2020
CompletedStudy Start
First participant enrolled
December 23, 2020
CompletedFirst Posted
Study publicly available on registry
December 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
July 22, 2025
July 1, 2025
8 years
December 23, 2020
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events after evaluation of PFO internal microstructure
cryptogenic stroke, transient ischemic attack , migraine or systemic embolism
5 years
Study Arms (3)
PFO patients with CS or/and TIA
PFO patients with CS or/and TIA (transcatheter closure of PFO was performed).
PFO patients with migraine
PFO patients with migraine (transcatheter closure of PFO was performed).
PFO patients without symptom
PFO patients without symptom (5-year follow-up).
Interventions
not appliable
Eligibility Criteria
This study will enroll subjects with PFO, and enrollment will be divided into three cohorts. Cohort 1: PFO patients with CS or/and TIA (transcatheter closure of PFO was performed). A minimum of 100 patients is reached. Cohort 2: PFO patients with migraine (transcatheter closure of PFO was performed). A minimum of 100 patients is reached. Cohort 3: PFO patients without symptom (5-year follow-up). A minimum of 100 patients is reached.
You may qualify if:
- 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).
You may not qualify if:
- 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;
- Evidence of hypercoagulable state;
- Allergic to contrast medium;
- Echocardiographic evidence of intra-cardiac thrombus, mass, tumor or vegetation;
- Active endocarditis or other infections.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China National Center for Cardiovascular Diseaseslead
- Beijing Anzhen Hospitalcollaborator
- The Affiliated Hospital of Xuzhou Medical Universitycollaborator
- Tibet Autonomous Region People's Hospitalcollaborator
- Beijing Tiantan Hospitalcollaborator
- Xuanwu Hospital, Beijingcollaborator
Study Sites (2)
Chaowu Yan
Beijing, Beijing Municipality, 100037, China
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
Related Publications (2)
Yan C, Li H, Wang C, Yu H, Guo T, Wan L, Yundan P, Wang L, Fang W. Frequency and Size of In Situ Thrombus Within Patent Foramen Ovale. Stroke. 2023 May;54(5):1205-1213. doi: 10.1161/STROKEAHA.122.041524. Epub 2023 Mar 9.
PMID: 36891906BACKGROUNDYan C, Li H. Preliminary Investigation of In situ Thrombus Within Patent Foramen Ovale in Patients With and Without Stroke. JAMA. 2021 May 25;325(20):2116-2118. doi: 10.1001/jama.2021.4359.
PMID: 34032839BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2020
First Posted
December 28, 2020
Study Start
December 23, 2020
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
July 22, 2025
Record last verified: 2025-07