RECRUITINGOBSERVATIONAL
Internal Microstructure of Patent Foramen Ovale Related to Stroke
Internal Microstructure of Patent Foramen Ovale Related to Cryptogenic Stroke, Transient Ischemic Attack or Migraine
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
1. Patients aged 16 to 65 years without any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity;
2. Documented PFO with right-to-left shunt ≥ 20 micro-bubbles by c-TCD;
3. Stroke group: history of ischemic stroke (based on brain magnetic resonance imaging) or TIA within 6 months without other identifiable causes (Phase1);
4. Migraine group: history of migraine headaches more than one year without other identifiable causes (Phase2);
5. Control group: incidental finding of PFO without neurological or systemic symptoms (Phase3).
Who Should NOT Join This Trial:
1. Any identifiable cause of ischemic stroke/TIA or migraine other than PFO;
2. History of stroke or TIA within the past one month;
3. Presence of cardiac enlargement or dysfunction;
4. Presence of coexisting cardiovascular structural malformations/diseases;
5. Presence of carotid artery lesions or coronary artery disease;
6. Presence of deep vein thrombosis or pulmonary embolism;
7. Presence of implanted cardiac devices;
8. Evidence of hypercoagulable state;
9. Allergic to contrast medium;
10. Echocardiographic evidence of intra-cardiac thrombus, mass, tumor or vegetation;
11. Active endocarditis or other infections.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Patients aged 16 to 65 years without any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity;
2. Documented PFO with right-to-left shunt ≥ 20 micro-bubbles by c-TCD;
3. Stroke group: history of ischemic stroke (based on brain magnetic resonance imaging) or TIA within 6 months without other identifiable causes (Phase1);
4. Migraine group: history of migraine headaches more than one year without other identifiable causes (Phase2);
5. Control group: incidental finding of PFO without neurological or systemic symptoms (Phase3).
Exclusion Criteria:
1. Any identifiable cause of ischemic stroke/TIA or migraine other than PFO;
2. History of stroke or TIA within the past one month;
3. Presence of cardiac enlargement or dysfunction;
4. Presence of coexisting cardiovascular structural malformations/diseases;
5. Presence of carotid artery lesions or coronary artery disease;
6. Presence of deep vein thrombosis or pulmonary embolism;
7. Presence of implanted cardiac devices;
8. Evidence of hypercoagulable state;
9. Allergic to contrast medium;
10. Echocardiographic evidence of intra-cardiac thrombus, mass, tumor or vegetation;
11. Active endocarditis or other infections.
Treatments Being Tested
OTHER
not appliable
not appliable
Locations (2)
Chaowu Yan
Beijing, Beijing Municipality, China
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
Beijing, Beijing Municipality, China