Comparing protein patterns in extracellular vesicles from different blood vessels in people with ruptured or unruptured brain aneurysms
Investigation of Protein Heterogeneity in Extracellular Vesicles Derived From Different Human Blood Circulatory Regions
This project tries to see if protein differences in extracellular vesicles taken from different blood vessels can help diagnose or predict outcomes for people with ruptured or unruptured brain aneurysms undergoing neurointerventional procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT07439965 on ClinicalTrials.gov |
What this trial studies
Researchers will collect blood during neurointerventional procedures from the femoral vein, internal jugular vein, and internal carotid artery of adults with ruptured or unruptured intracranial aneurysms. Extracellular vesicles will be isolated from those samples and analyzed with proteomic methods to map protein differences across vascular locations and between hemorrhagic and non-hemorrhagic cases. The study focuses on patients aged 18–60 who are undergoing treatment under general anesthesia, with ruptured cases sampled within three days of symptom onset. As an observational project, there is no treatment intervention; findings aim to identify candidate EV-derived protein biomarkers linked to diagnosis and prognosis.
Who should consider this trial
Good fit: Adults aged 18–60 with a confirmed intracranial aneurysm who are scheduled for neurointerventional treatment under general anesthesia (ruptured cases sampled within three days) and who can give informed consent.
Not a fit: People older than 60, those with significant preexisting neurological or systemic diseases, a baseline mRS ≥2, or those not undergoing neurointervention are unlikely to be eligible or benefit from this observational protocol.
Why it matters
Potential benefit: If successful, this work could identify blood-based protein markers from specific vascular sites that improve diagnosis and prognosis after subarachnoid hemorrhage.
How similar studies have performed: Prior studies have identified diagnostic signals in extracellular vesicles from peripheral blood, but sampling proteomic heterogeneity across head and neck arterial and venous sites during neurointervention is a novel approach that has not yet been validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Aged between 18 and 60 years, regardless of gender; 2. Diagnosed with intracranial aneurysm confirmed by MRA, CTA, or DSA; 3. Patients with aneurysmal subarachnoid hemorrhage must have CT imaging evidence of hemorrhage, and blood collection must occur within 3 days of symptom onset; 4. Scheduled to undergo neurointerventional surgery for intracranial aneurysm under general anesthesia, with the procedure starting between 8:00 AM and 12:00 PM; 5. Willing to comply with the study protocol and data collection procedures; 6. Able to understand and sign the informed consent form. Exclusion Criteria: * 1\. Patients with a pre-onset (in hemorrhagic cases) or preoperative (in non-hemorrhagic cases) Modified Rankin Scale (MRS) score ≥ 2; 2. Presence of other neurological disorders such as Parkinson's disease, Alzheimer's disease, cerebral infarction, brain tumors, epilepsy, etc.; 3. Presence of other systemic diseases such as diabetes, coronary artery disease, cancer, infections, hematological diseases, or severe metabolic disorders that may significantly affect the evaluation of blood EVs; 4. History of severe hepatic or renal dysfunction (ALT \> 3 times the upper limit of normal; creatinine \> 225 μmol/L); 5. Patients who cannot tolerate anesthesia, anticoagulant therapy, or who have coagulation disorders; 6. History of severe allergic reactions to contrast agents; 7. Pregnant women; 8. Patients participating in other clinical trials who have not yet completed follow-up.
Where this trial is running
Changchun, Jilin
- First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
Study contacts
- Study coordinator: Zheng Wan, Medical Doctor， MD
- Email: wanzheng@jlu.edu.cn
- Phone: 86-18743059601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.