Investigation of Protein Heterogeneity in Extracellular Vesicles Derived From Different Human Blood Circulatory Regions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorThe First Hospital of Jilin University

About this trial

The goal of this observational study is to learn about the protein heterogeneity in extracellular vesicles (EVs) derived from different human blood circulatory regions of patients with ruptured or unruptured intracranial aneurysms. The main objectives are:

Reveal the proteomic heterogeneity of EVs in different blood circulatory regions of the human body。 Reveal the proteomic differences of EVs in cerebral feeding arteries and draining veins between patients with aneurysmal subarachnoid hemorrhage and those without hemorrhage.

Explore EV-derived protein biomarkers that reflect the diagnosis and prognosis of subarachnoid hemorrhage

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

This is an exploratory study, and to date, there have been no similar reports in the literature. The primary outcome will be differences in proteomic profiles, which may yield hundreds of differential results. Based on the planned budget and clinical experience, we preliminarily aim to enroll 60 patients with aneurysmal subarachnoid hemorrhage and 60 patients with unruptured intracranial aneurysms. Proteomic analysis of extracellular vesicles from the first 30 patients will be used to identify intergroup differential markers of interest, which will then guide further adjustments to the sample size in the subsequent phase of the study.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: Patients with ruptured intracranial aneurysms
Group B: Patients with unruptured intracranial aneurysms

Trial outcomes

Primary outcomes

1

Proteomics of extracellular vesicles (EVs) derived from different blood circulatory regions

During neurointerventional procedures under general anesthesia, 5 mL of blood will be collected from the patient's femoral vein, internal jugular vein, and internal carotid artery. After centrifugation to obtain plasma, extracellular vesicles will be extracted for proteomic detection and analysis.

Time frame
From enrollment to the end of treatment at 7 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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