RecruitingNCT04686253

Internal Microstructure of Patent Foramen Ovale Related to Stroke

Internal Microstructure of Patent Foramen Ovale Related to Cryptogenic Stroke, Transient Ischemic Attack or Migraine

Sponsor

China National Center for Cardiovascular Diseases

Enrollment

1,200 participants

Start Date

Dec 23, 2020

Study Type

OBSERVATIONAL

Conditions

Patent foramen ovale

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.

Eligibility

Min Age: 16 YearsMax Age: 65 Years

Inclusion Criteria5

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 Criteria11

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.