Internal Microstructure of Patent Foramen Ovale Related to Stroke (NCT04686253) | Clinical Trial Compass
RecruitingNot Applicable
Internal Microstructure of Patent Foramen Ovale Related to Stroke
China1,200 participantsStarted 2020-12-23
Plain-language 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-upï¼›(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 participate
Age range16 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
What they're measuring
1
Adverse Events after evaluation of PFO internal microstructure
Timeframe: 5 years
Trial details
NCT IDNCT04686253
SponsorChina National Center for Cardiovascular Diseases