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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 65
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Chaowu Yan
RECRUITING
Beijing
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
RECRUITING
Beijing
Contact Information
Primary
Chaowu Yan, PhD and MD
chaowuyan@163.com
+861088398408
Time Frame
Start Date: 2020-12-23
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 1200
Treatments
PFO patients with CS or/and TIA
PFO patients with CS or/and TIA (transcatheter closure of PFO was performed).
PFO patients with migraine
PFO patients with migraine (transcatheter closure of PFO was performed).
PFO patients without symptom
PFO patients without symptom (5-year follow-up).
Sponsors
Collaborators: Beijing Anzhen Hospital, The Affiliated Hospital of Xuzhou Medical University, Tibet Autonomous Region People's Hospital
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov