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Clinical Trials/NCT06729385
NCT06729385
Completed
Not Applicable

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

Capital Medical University4 sites in 1 country80 target enrollmentDecember 1, 2024
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Capital Medical University
Enrollment
80
Locations
4
Primary Endpoint
Primary Outcome Measures:
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2024
End Date
February 20, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Capital Medical University
Responsible Party
Principal Investigator
Principal Investigator

Ji Xunming,MD,PhD

MD.PhD

Capital Medical University

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Primary Outcome Measures:

Time Frame: 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.

Study Sites (4)

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