Blood Proteome Profiling Identifies Biomarkers in Ischemic Stroke

The Blood Proteome Profiling Identifies Biomarkers Associated with Prognosis in Ischemic Stroke Due to Large Artery Atherosclerosis

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Diagnostic test: The blood Proteome Profiling

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 409900
      • People's hospital of Xiushan Country
  • Henan
    • Nanyang, Henan, China, 473065
      • Nanyang Nanshi Hospital
  • Hunan
    • Changsha, Hunan, China, 410399
      • Liuyang Jili Hospital, Hunan, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with large artery atherosclerotic ischemic stroke, presenting 7 to 30 days after onset, and who have not received reperfusion therapy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obvious group; Patients with large artery atherosclerotic ischemic stroke, presenting 7 to 30 days after onset, and who have not received reperfusion therapy.	Diagnostic test: The blood Proteome Profiling; Patients who meet the inclusion criteria will undergo fasting blood collection for proteomics analysis upon admission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measures:	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.	3 months

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: PBIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No