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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

This trial does not accept healthy volunteers

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 population

This study will enroll subjects with PFO, and enrollment will be divided into three cohorts. Cohort 1: PFO patients with CS or/and TIA (transcatheter closure of PFO was performed). A minimum of 100 patients is reached. Cohort 2: PFO patients with migraine (transcatheter closure of PFO was performed). A minimum of 100 patients is reached. Cohort 3: PFO patients without symptom (5-year follow-up). A minimum of 100 patients is reached.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • not appliable

    Other intervention

    not appliable

Treatment groups

1,200 Participants
are divided into 3 treatment groups
Group A: PFO patients with CS or/and TIA1 intervention
Group B: PFO patients with migraine1 intervention
Group C: PFO patients without symptom1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events after evaluation of PFO internal microstructure

cryptogenic stroke, transient ischemic attack , migraine or systemic embolism

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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