StrokeNCT06665386
Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics.
An observational study of Stroke and Hypothermia Treatment, run by Capital Medical University at 1 site in China.
Trial summary
Endovascular Thrombectomy has emerged as a pivotal treatment modality for acute ischemic stroke. However, despite successful thrombus removal, a substantial proportion of patients still experience poor outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Hypothermia Treatment
- What is being tested?
- hypothermia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2024to 28 Feb 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Blood samples were collected from patients who underwent Endovascular Thrombectomy alone and those who received selective intra-arterial cooling infusion combined with Endovascular Thrombectomy. The supernatant was separated by centrifugation and stored in a -80°C refrigerator.
Who may be able to join
- Age ≥18 and ≤80.
- Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (intracranial segment of the internal carotid artery, middle cerebral artery M1 segment) demonstrated with CTA/MRA/DSA.
- NIHSS score obtained prior to randomization ≥6 and ≤25.
- Modified Rankin Scale ≤ 1 prior to qualifying stroke.
- Arterial puncture performed within 24 hours from symptom onset or LKW.
- For the patients with symptom onset within 6 hours, the ASPECT score ≥6; for the patientswith onset within 6-24 hours, the therapy should meet the imaging criteria of DAWN or DEFUSE-3 trial.
- Patient/Legally Authorized Representative has signed the Informed Consent Form.
Who cannot join
- Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
- Baseline CT/MRI confirms the presence of arterial dissection.
- Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
- Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
- Severe infection (e.g. sepsis) or multiple organ failure.
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 3. Patients on factor Xa inhibitor for 48 hours ago must have a normal APTT.
Show all 19Show fewer
- Baseline platelet count <50 × 109/L.
- Blood glucose concentration<50 mg/dL (2.7mmol/L) or >400 mg/dL (22.2mmol/L).
- Refractory hypertension that is difficult to control by medication (Defined as persistent systolic blood pressure>185 mmHg or diastolic blood pressure>110mmHg).
- Previous NHYA>1.
- Untreated moderate or severe coronary artery stenosis, or previous coronary artery bypass surgery.
- Undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency with glomerular filtration rate <30 ml/min or serum creatinine >220 mmol/L (2.5mg/dl).
- Known intracranial aneurysm, and cerebral arteriovenous malformation.
- Malignant brain tumor or CNS infection.
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)
- Female who is pregnant or lactating at time of admission.
- Anticipated life expectancy <6 months.
- Current participation in another investigational drug or device study.
- For other reasons, the responsible clinicians believe that the patient is not suitable for continued treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dalian Municipal Central Hospital
Dalian, Liaoning, 116000
Di Li, +86 83198290, Hejiachen9907@outlook.com
About this study
Endovascular Thrombectomy has emerged as a pivotal treatment modality for acute ischemic stroke. However, despite successful thrombus removal, a substantial proportion of patients still experience poor outcomes. Selective intra-arterial cooling has shown promise in decelerating stroke progression and providing neuroprotection. This study aims to identify biomarkers associated with the combination of selective intra-arterial cooling infusion and endovascular thrombectomy in the treatment of ischemic stroke by integrating proteomics and metabolomics data. Our study is based on the multicenter RCT study "Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke." All samples were derived from this experiment. Our objective is to elucidate the molecular mechanisms underlying the prognostic impact of this combined therapeutic approach, providing insights to optimize stroke treatment strategies.
- Conditions
- Stroke, Hypothermia Treatment
- Being tested
- hypothermia
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypothermiaProcedure or surgery
Patients who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned to either the control group or the IA-SCI group. Control group patients will receive BMM and EVT. IA-SCI group patients will receive BMM and EVT, and additionally a selective intraarterial cooling infusion. The specific method is as follows:
- Pre-recanalization: During the procedure, a micro-catheter used to deploy the stent retriever is threaded coaxially into the common femoral artery through the guide catheter. The microcatheter is advanced over a microguide wire, traveling up through the neck until it reaches beyond the clot. A 50 mL cold 0.9% saline (4℃) is infused into the ischemic territory at a rate of 10 mL/min via the microcatheter. This enables the cold solution to infuse into the ischemic territory prior to revascularization.
- Post-recanalization: Following vessel recanalization, cold 0.9% saline (4 ℃) is reinfused into the vessel via the catheter at a rate of 22 mL
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Patients will receive best medical management (BMM) plus EVT according to the clinical guidelines. | |
| IA-SCI group | Patients will receive BMM and EVT combined with selective intra-arterial cold saline infusion. Receives: Procedure: hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics.
Measure Description:
By integrating proteomics and metabolomics data, researchers were able to identify common pathways and mechanisms through which selective intra-arterial cooling infusion combined with endovascular thrombectomy influences the prognosis of ischemic stroke.
Time Frame:3 months
Measured: 2024-10-2025-2
Secondary outcomes (1)
Secondary Outcome
- Quantitative changes of individual metabolites and proteins were calculated and graphed using the KEGG mapping tools.
- All of the omics data were used to compare proteins/enzymes with metabolic pathways.
- By integrating proteomics and metabolomics data, researchers were able to identify common pathways and mechanisms through which selective intra-arterial cooling infusion combined with endovascular thrombectomy influences the prognosis of ischemic stroke.
Time Frame:3 months
Measured: 2024-10-2025-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start27 Oct 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
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
- Retrospective
- Enrolment
- 258 participants (estimated)
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
- NCT06665386
- Sponsor's protocol ID
- PBIA
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics.
- ClinicalTrials.gov ID
- NCT06665386
- Acronym / sponsor ID
- PBIA
- Conditions
- Stroke, Hypothermia Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 27 Oct 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 30 Oct 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 has emerged as a pivotal treatment modality for acute ischemic stroke. However, despite successful thrombus removal, a substantial proportion of patients still experience poor outcomes. Selective intra-arterial cooling has shown promise in decelerating stroke progression and providing neuroprotection. This study aims to identify biomarkers associated with the combination of selective intra-arterial cooling infusion and endovascular thrombectomy in the treatment of ischemic stroke by integrating proteomics and metabolomics data. Our study is based on the multicenter RCT study "Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke." All samples were derived from this experiment. Our objective is to elucidate the molecular mechanisms underlying the prognostic impact of this combined therapeutic approach, providing insights to optimize stroke treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Patients will receive best medical management (BMM) plus EVT according to the clinical guidelines. |
| IA-SCI group | – | Procedure: hypothermiaPatients will receive BMM and EVT combined with selective intra-arterial cold saline infusion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Blood samples were collected from patients who underwent Endovascular Thrombectomy alone and those who received selective intra-arterial cooling infusion combined with Endovascular Thrombectomy. The supernatant was separated by centrifugation and stored in a -80°C refrigerator.
Key inclusion criteria (7 listed)
- Age ≥18 and ≤80.
- Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (intracranial segment of the internal carotid artery, middle cerebral artery M1 segment) demonstrated with CTA/MRA/DSA.
- NIHSS score obtained prior to randomization ≥6 and ≤25.
- Modified Rankin Scale ≤ 1 prior to qualifying stroke.
- Arterial puncture performed within 24 hours from symptom onset or LKW.
Key exclusion criteria (19 listed)
- Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
- Baseline CT/MRI confirms the presence of arterial dissection.
- Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
- Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
- Severe infection (e.g. sepsis) or multiple organ failure.
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 |
|---|---|---|
| hypothermiaPatients who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned to either the control group or the IA-SCI group. Control group patients will receive BMM and EVT. IA-SCI group patients will receive BMM and EVT, and additionally a selective intraarterial cooling infusion. The specific method is as follows: * Pre-recanalization: During the procedure, a micro-catheter used to deploy the stent retriever is threaded coaxially into the common femoral artery through the guide catheter. The microcatheter is advanced over a microguide wire, traveling up through the neck until it reaches beyond the clot. A 50 mL cold 0.9% saline (4℃) is infused into the ischemic territory at a rate of 10 mL/min via the microcatheter. This enables the cold solution to infuse into the ischemic territory prior to revascularization. * Post-recanalization: Following vessel recanalization, cold 0.9% saline (4 ℃) is reinfused into the vessel via the catheter at a rate of 22 mL | Procedure or surgery | IA-SCI group |
Primary outcome
Primary Outcome
Time frame: 2024-10-2025-2
Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics. Measure Description: By integrating proteomics and metabolomics data, researchers were able to identify common pathways and mechanisms through which selective intra-arterial cooling infusion combined with endovascular thrombectomy influences the prognosis of ischemic stroke. Time Frame:3 months
1 secondary outcome
Secondary Outcome
Time frame: 2024-10-2025-2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hypothermia Treatment, run by Capital Medical University at 1 site 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 7 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji, Professor (+86 17600104266, chenxi00cx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 2024-10-2025-2). 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 12 Dec 2024.