Investigating the internal structure of patent foramen ovale related to stroke and migraine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the internal microstructure of patent foramen ovale (PFO) in patients with cryptogenic stroke, transient ischemic attack, or migraine. It will evaluate the effectiveness of transcatheter closure in these patients and assess the microstructural features of asymptomatic individuals with PFO. Additionally, the study will conduct untargeted metabolomics analysis using plasma samples from both the right and left atrium, alongside shunt provocative tests. The goal is to better understand PFO and improve risk stratification for patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged 16 to 65 years without any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity;
2. Documented PFO with right-to-left shunt ≥ 20 micro-bubbles by c-TCD;
3. Stroke group: history of ischemic stroke (based on brain magnetic resonance imaging) or TIA within 6 months without other identifiable causes (Phase1);
4. Migraine group: history of migraine headaches more than one year without other identifiable causes (Phase2);
5. Control group: incidental finding of PFO without neurological or systemic symptoms (Phase3).

Exclusion Criteria:

1. Any identifiable cause of ischemic stroke/TIA or migraine other than PFO;
2. History of stroke or TIA within the past one month;
3. Presence of cardiac enlargement or dysfunction;
4. Presence of coexisting cardiovascular structural malformations/diseases;
5. Presence of carotid artery lesions or coronary artery disease;
6. Presence of deep vein thrombosis or pulmonary embolism;
7. Presence of implanted cardiac devices;
8. Evidence of hypercoagulable state;
9. Allergic to contrast medium;
10. Echocardiographic evidence of intra-cardiac thrombus, mass, tumor or vegetation;
11. Active endocarditis or other infections.

Where it's running

• Chaowu Yan
  Beijing, Beijing Municipality, China Recruiting
• National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Chaowu Yan, PhD and MD
• Email: chaowuyan@163.com
• Phone: +861088398408

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term outcomes after PFO closure at Severance Hospital

  This registry tests how well percutaneous PFO closure works over the long term and what factors predict residual shunt, new atrial fibrillation, or other outcomes in adults who had the procedure.

  Recruiting Yonsei University · Seoul · NCT07724171

• P3 Occluder System for closing a heart opening (PFO) after stroke

  We are testing the P3 Occluder System to see if it safely and effectively closes a patent foramen ovale in adults who had a stroke related to their heart opening.

  Recruiting Recross Cardio, Inc. · Belgrade · NCT07698951

• PFO-Directed Therapy for Migraines: Closing the Hole or Using a Blood Thinner

  This study tests whether closing a patent foramen ovale (PFO) plus 24 weeks of prasugrel works better for long-term migraine relief than prasugrel alone in people whose migraines improve on blood-thinning therapy.

  Recruiting Phase 3 Columbia University · New York, New York · NCT07629635

• Comparing Cocoon vs Amplatzer PFO Occluders in Adults After Stroke or TIA

  This trial tests whether the Cocoon PFO Occluder works as well as the Amplatzer PFO Occluder in adults who had a cryptogenic stroke or TIA and have a PFO requiring closure.

  Recruiting Sahajanand Medical Technologies Limited · Bad Oeynhausen, North Rhine-Westphalia (Nordrhein-Westfalen) · NCT07380490

• Percutaneous repair of the atrial septum using the P3 Occluder System for PFO closure

  This trial tests the P3 Occluder System to close a patent foramen ovale (PFO) in adults 18–65 who have had a stroke that may be linked to their PFO.

  Recruiting at 5 sites Recross Cardio, Inc. · Los Angeles, California and 4 other locations · NCT07172464

• Closing a PFO to improve glymphatic function and migraine symptoms

  This study will see if closing a patent foramen ovale (PFO) improves glymphatic system function and reduces migraine attacks in adults with PFO and migraine.

  Recruiting at 2 sites First Affiliated Hospital Xi'an Jiaotong University · Luoyang, Henan and 1 other locations · NCT07170176

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.