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CompletedNCT06729385Updated Feb 21, 2025

Blood Proteome Profiling Identifies Biomarkers in Ischemic Stroke

An observational study in Stroke, sponsored by Capital Medical University. Completed at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.

Sponsored by Capital Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Stroke

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03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 80 is below the median of 160 across 1,729 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Capital Medical University is the lead sponsor of 293 studies on the registry; 91 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testThe blood Proteome Profiling

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

06

What researchers measure

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.

    Time frame: 3 months

07

Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2024 to primary completion in Feb 2025, 2 months.

Of 787 non-industry observational studies under Stroke, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 101. This study's 2 months is below that.

Counting every sponsor, half of 833 studies reached it within 41 months; a quarter within 18 and three quarters within 92.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2024
First posted
Dec 11, 2024
StartActual
Dec 1, 2024
Primary completionActual
Feb 20, 2025
CompletionActual
Feb 20, 2025
Last update
Feb 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06729385
Responsible party
Ji Xunming,MD,PhD (MD.PhD, Capital Medical University) — Principal investigator
First posted
Dec 11, 2024
Start date
Dec 1, 2024
Primary completion
Feb 20, 2025
Completion
Feb 20, 2025
Last update
Feb 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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