StrokeNCT06729385
Blood Proteome Profiling Identifies Biomarkers in Ischemic Stroke
An observational study of Stroke, run by Capital Medical University at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- The blood Proteome Profiling
- How many people
- 80 participants
- Where
- 4 sitesChina
- Study dates
- 1 Dec 2024to 20 Feb 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with large artery atherosclerotic ischemic stroke, presenting 7 to 30 days after onset, and who have not received reperfusion therapy.
Who may be able to join
- Age ≥18.
- Clinical signs consistent with acute ischemic stroke (TOAST classification: large artery atherosclerosis)
- 7 to 30 days from symptom onset.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Xuanwu Hospital
Beijing, Beijing Municipality, 100053
Liuyang Jili Hospital, Hunan, China
Changsha, Hunan, 410399
People's hospital of Xiushan Country
Chongqing, Chongqing Municipality, 409900
Nanyang Nanshi Hospital
Nanyang, Henan, 473065
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- The blood Proteome Profiling
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The blood Proteome ProfilingDiagnostic test
Patients who meet the inclusion criteria will undergo fasting blood collection for proteomics analysis upon admission.
| Study group | Role | What they receive |
|---|---|---|
| Obvious group | Patients with large artery atherosclerotic ischemic stroke, presenting 7 to 30 days after onset, and who have not received reperfusion therapy. Receives: Diagnostic Test: The blood Proteome Profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Dec 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729385
- Sponsor's protocol ID
- PBIS
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Blood Proteome Profiling Identifies Biomarkers Associated with Prognosis in Ischemic Stroke Due to Large Artery Atherosclerosis
- ClinicalTrials.gov ID
- NCT06729385
- Acronym / sponsor ID
- PBIS
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obvious group | – | Diagnostic Test: The blood Proteome ProfilingPatients with large artery atherosclerotic ischemic stroke, presenting 7 to 30 days after onset, and who have not received reperfusion therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with large artery atherosclerotic ischemic stroke, presenting 7 to 30 days after onset, and who have not received reperfusion therapy.
Key inclusion criteria (3 listed)
- Age ≥18.
- Clinical signs consistent with acute ischemic stroke (TOAST classification: large artery atherosclerosis)
- 7 to 30 days from symptom onset.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The blood Proteome ProfilingPatients who meet the inclusion criteria will undergo fasting blood collection for proteomics analysis upon admission. | Diagnostic test | Obvious group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Capital Medical University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measures: (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.