Status:
RECRUITING
Internal Microstructure of Patent Foramen Ovale Related to Stroke
Lead Sponsor:
China National Center for Cardiovascular Diseases
Collaborating Sponsors:
Beijing Anzhen Hospital
The Affiliated Hospital of Xuzhou Medical University
Conditions:
Patent Foramen Ovale
Eligibility:
All Genders
16-65 years
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 transcath...
Detailed Description
Patent foramen ovale (PFO) is associated with a variety of pathological conditions, and it is presumed to be related to the occurrence of cryptogenic stroke (CS), transient ischemic attack (TIA) or mi...
Eligibility Criteria
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;
- Evidence of hypercoagulable state;
- Allergic to contrast medium;
- Echocardiographic evidence of intra-cardiac thrombus, mass, tumor or vegetation;
- Active endocarditis or other infections.
Key Trial Info
Start Date :
December 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04686253
Start Date
December 23 2020
End Date
December 31 2028
Last Update
July 22 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Chaowu Yan
Beijing, Beijing Municipality, China, 100037
2
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
Beijing, Beijing Municipality, China, 100037