Internal Microstructure of Patent Foramen Ovale Related to Stroke
ConditionPatent Foramen Ovale
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-65
SponsorChina National Center for Cardiovascular Diseases
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- not appliable
Treatment groups
1,200 Participants
are divided into 3 treatment groupsSponsors and collaborators
China National Center for Cardiovascular Diseases
Lead sponsor
Beijing Anzhen Hospital
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
Tibet Autonomous Region People's Hospital
Collaborator
Beijing Tiantan Hospital
Collaborator
Xuanwu Hospital, Beijing
Collaborator
Source ClinicalTrials.gov