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Development and validation of an ultrasound radiomics-based risk prediction model for patent foramen ovale-related cryptogenic stroke in young and middle-aged adults

Development and validation of an ultrasound radiomics-based risk prediction model for patent foramen ovale-related cryptogenic stroke in young and middle-aged adults

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127206
Enrollment
Unknown
Registered
2026-06-26
Start date
2026-06-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease or Condition: Ischemic Stroke, Cryptogenic (or Cryptogenic Ischemic Stroke)

Interventions

Case group (Stroke group):None
Control group (Non-stroke group):None

Sponsors

Jiaxing First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Case group (Stroke group, n=100): (1) Aged 18–60 years; (2) Definite diagnosis of cryptogenic stroke or embolic stroke of undetermined source (ESUS); (3) Confirmed PFO with RLS by TEE combined with cTTE; (4) Time from symptom onset to ultrasound examination <=30 days. 2. Control group (Non-stroke group, n=150): (1) Age-matched (+/-3 years); (2) Confirmed PFO with RLS; (3) No history of stroke or transient ischemic attack (TIA); (4) No infarct lesions on brain imaging.

Exclusion criteria

Exclusion criteria: 1. Other intracranial lesions, such as hemorrhagic stroke, intracranial hematoma, intracranial infection, etc.; 2. Other vascular diseases, such as atherosclerosis, arterial dissection, vascular malformation, etc.; 3. Concomitant severe organic heart disease (including structural or functional remodeling of the heart); 4. Malignant tumors; 5. Rheumatic or autoimmune diseases; 6. History of severe trauma; 7. Inability to cooperate with the examination.

Design outcomes

Primary

MeasureTime frame
Risk of cryptogenic stroke related to patent foramen ovale in young and middle-aged adults;

Secondary

MeasureTime frame
Ultrasound radiomics signature (Rad-Score);Conventional echocardiographic parameters;Contrast transthoracic echocardiography (cTTE) results (right-to-left shunt grading);Model performance metrics;

Countries

China

Contacts

Public ContactWeng ChaoHui

Jiaxing First Hospital

593145787@qq.com+86 573 82519663

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026