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

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

This study is trying to learn more about the tiny structures of a heart condition called patent foramen ovale (PFO) in people who have had a stroke, a mini-stroke, or migraines, to see if closing it helps and to understand the risks better.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Ages: 16 Years to 65 Years
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT04686253 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients aged 16 to 65 with documented PFO and a history of ischemic stroke, transient ischemic attack, or migraine.

Not a fit: Patients with identifiable causes of ischemic stroke, TIA, or migraine other than PFO will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved risk assessment and treatment strategies for patients with patent foramen ovale.

How similar studies have performed: While the investigation of PFO's microstructure is a relatively novel approach, similar studies have shown promise in understanding its implications for stroke and migraine.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 1 other locations

• 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

Conditions Patent Foramen Ovale; patent foramen ovale; stroke; transient ischemic attack; migraine; microstructure