Blood Proteome Profiling Identifies Biomarkers in Ischemic Stroke

Completed

• Conditions: Stroke

• Registration Number: NCT06729385
• Lead Sponsor: Capital Medical University

Brief Summary

Endovascular thrombectomy and intravenous thrombolysis have become key therapeutic approaches for acute ischemic stroke. However, due to time window limitations, many patients are unable to receive reperfusion therapy, and the majority only receive supportive treatment. Ischemic stroke-related complications, including edema and infection, gradually subside after 7 days post-stroke, with the patient's condition generally stabilizing. Endogenous repair mechanisms will play a critical role in the coming months. This study aims to predict prognostic biomarkers for ischemic stroke patients who have not undergone reperfusion therapy, using blood proteomics data. All samples in our study are derived from this experiment. Our goal is to elucidate the molecular mechanisms underlying post-reperfusion prognosis and to provide insights for optimizing stroke treatment strategies.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-08
• Study First Posted: 2024-12-11
• Last Update Submitted: 2025-02-19
• Primary Completion: 2025-02-20
• Study Completion: 2025-02-20
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age ≥18.
• Clinical signs consistent with acute ischemic stroke (TOAST classification: large artery atherosclerosis)
• 7 to 30 days from symptom onset.

Exclusion Criteria

• Severe infection or multiple organ failure.
• Untreated moderate or severe coronary artery stenosis, or a history of coronary artery bypass surgery.
• Ongoing hemodialysis or peritoneal dialysis, or severe renal insufficiency characterized by a glomerular filtration rate (GFR) of less than 30 ml/min or serum creatinine levels exceeding 220 mmol/L (2.5 mg/dl).
• Known intracranial aneurysm or cerebral arteriovenous malformation.
• Malignant brain tumor or central nervous system (CNS) infection.
• Pre-existing neurological or psychiatric conditions that could confound the neurological or functional assessments.
• Baseline platelet count <50 × 109/L.
• Pregnancy or lactation at the time of admission.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measures:	3 months	Modified Rankin Scale score (mRS) at 90 days The Modified Rankin Scale (mRS) at 90 days was used to assess functional outcomes. The mRS is a widely utilized scale to measure the degree of disability or dependence in daily activities among stroke patients.; Minimum value: 0 (indicating no symptoms or disability) Maximum value: 6 (indicating death) Interpretation: Higher scores represent worse outcomes, reflecting greater levels of disability or mortality.

Trial Locations

Locations (4)

Xuanwu Hospital; 🇨🇳 Beijing, Beijing, China

People's hospital of Xiushan Country; 🇨🇳 Chongqing, Chongqing, China

Nanyang Nanshi Hospital; 🇨🇳 Nanyang, Henan, China

Liuyang Jili Hospital, Hunan, China; 🇨🇳 Changsha, Hunan, China