China National Center for Cardiovascular Diseases
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.
Patent Foramen Ovale
not appliable
Patent foramen ovale (PFO) is associated with a variety of pathological conditions, and it is presumed to be related to the occurrence of cryptogenic stroke (CS), transient ischemic attack (TIA) or migraine. In addition, the main hypothesized pathophysiologic mechanism is paradoxical embolization, namely microemboli or metabolites from the venous circulation to enter the systemic circulation. The morphological characteristics of PFO have the potential to predict risks and screen the appropriate candidates for transcatheter closure. The structure features for predicting risk included atrial septal aneurysm, a large right-left shunt, long-tunnel PFO and so on. However, the in-vivo internal microstructure of PFO is still unclear. The microstructural features might provide important information for better understanding the PFO and risk stratification. The aim of this study is 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. This study will enroll subjects with PFO, and enrollment will be divided into three phases. Phase 1: PFO patients with CS or/and TIA (transcatheter closure of PFO was performed). A minimum of 500 patients is reached. Phase 2: PFO patients with migraine (transcatheter closure of PFO was performed). A minimum of 500 patients is reached. Phase 3: PFO patients without symptom (5-year follow-up). A minimum of 200 patients is reached. In addition, blood samples were obtained, including inferior vena cava, superior vena cava, right atrium, PFO-tunnel, left pulmonary artery, left atrium and left pulmonary vein. Then, another 20 ml blood sample was obtained from right atrium (near PFO) and injected into left atrium immediately. During a ten-minute waiting period, any symptom was recorded.
| Study Type : | OBSERVATIONAL |
| Estimated Enrollment : | 1200 participants |
| Official Title : | Internal Microstructure of Patent Foramen Ovale Related to Cryptogenic Stroke, Transient Ischemic Attack or Migraine |
| Actual Study Start Date : | 2020-12-23 |
| Estimated Primary Completion Date : | 2028-12-31 |
| Estimated Study Completion Date : | 2028-12-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 16 Years to 65 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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RECRUITING
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Beijing, Beijing Municipality, China, 100037
RECRUITING
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
Beijing, Beijing Municipality, China, 100037