Blood Proteome Profiling Identifies Biomarkers in Ischemic Stroke

NCT06729385 | Completed

• 1 other identifier: PBIS
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 4

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

The blood Proteome Profiling DIAGNOSTIC_TEST

Patients who meet the inclusion criteria will undergo fasting blood collection for proteomics analysis upon admission.

Obvious group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (4)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

Location

People's hospital of Xiushan Country

Chongqing, Chongqing Municipality, 409900, China

Location

Nanyang Nanshi Hospital

Nanyang, Henan, 473065, China

Location

Liuyang Jili Hospital, Hunan, China

Changsha, Hunan, 410399, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.PhD

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: February 21, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)