Internal Microstructure of Patent Foramen Ovale Related to Stroke
Recruiting · NCT04686253 · Observational (researchers observe without assigning treatment) · Lead sponsor: China National Center for Cardiovascular Diseases
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
2 locations listed.
- Chaowu Yan - Beijing, Beijing Municipality, China
- National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital - Beijing, Beijing Municipality, China