Stroke, AcuteNCT06170086
Early Neurological Trajectory and Clinical Outcomes in Brain Acute Ischemic Stroke
An observational study of Stroke, Acute, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Prospective identification of potential responsible blood vessels, provision of intervention targets, prevention of fatal and disabling cerebrovascular diseases, identification of early END patients, determination of clinical treatment pathways, improvement of efficacy, and improvement of prognosis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: A. Acute Perforating artery stroke patients within 48 hours of onset; B. Age ≥ 18 years and ≤ 80 years old; C. Have two or more vascular risk factors, including hypertension, diabetes, coronary heart disease, hyperlipidemia, smoking and obesity; D. Sign an informed consent form;
Who may be able to join
- Acute Perforating artery stroke patients within 48 hours of onset; B. Age ≥ 18 years and ≤ 80 years old; C. Have two or more vascular risk factors, including hypertension, diabetes, coronary heart disease, hyperlipidemia, smoking and obesity; D. Sign an informed consent form;
Who cannot join
- Patients with large artery stroke; B. Contraindications to magnetic resonance imaging or pregnant women; C. Other vascular lesions, such as aneurysms, vascular dissection, vasculitis, and brain tumors;
Trial locations and contacts
1 site in 1 country.
About this study
Prospective identification of potential responsible blood vessels, provision of intervention targets, prevention of fatal and disabling cerebrovascular diseases, identification of early END patients, determination of clinical treatment pathways, improvement of efficacy, and improvement of prognosis
Read the detailed description
- Research background： Stroke is divided into ischemic stroke and hemorrhagic stroke, with ischemic stroke accounting for about 70% and being the main type of stroke. The branch atherosclerotic disease (BAD) accounts for 10%~15% of all acute ischemic stroke (ALS), mainly involving lenticular artery (LSA), parapontine median artery (PPA), thalamic geniculate body artery, anterior choroidal artery Heubner's artery and thalamic perforating artery. Its clinical symptoms often manifest as early neurological deterioration (END), mainly progressive motor dysfunction (PDM), within 48 to 72 hours of onset, with an incidence rate of approximately 17% -75%. The clinical prognosis is poor.
- The purpose and significance of the research Prospective identification of potential responsible blood vessels, provision of intervention targets, prevention of fatal and disabling cerebrovascular diseases, identification of early END patients, determination of clinical treatment pathways, improvement of efficacy, and improvement of prognosis
- Research contents 1) Research on the relationship between stroke responsibility vessels and the pathogenesis of END in patients based on magnetic resonance three-dimensional time leap vascular imaging technology; 2) The impact of clinical interventions (intravenous thrombolysis, antiplatelet therapy, anticoagulation, statins, neuroprotective drugs, etc.) on END
- Patient inclusion and exclusion criteria inclusion criteria
- Acute perforating atherosclerotic stroke patients within 48 hours of onset;
- Age ≥ 18 years and ≤ 80 years old;
- Having two or more vascular risk factors, including hypertension, diabetes, coronary heart disease, hyperlipidemia, smoking and obesity;
- Sign informed consent form exclusion criteria <!-- -->
- Patients with large artery stroke;
- Contraindications to magnetic resonance imaging or pregnant women;
- Other vascular lesions, such as aneurysms, vascular dissection, vasculitis, and brain tumors
- Research method Select and treat emergency stroke patients according to the research design requirements, record clinical data, and evaluate the timing of 7T MRI. The patient underwent 7T MRI examination within 24 hours after the first diagnosis of acute stroke of the perforating artery, within 24 hours after aggravation, and 2 weeks after treatment according to the consensus of Chinese experts on perforating artery atherosclerosis. The sequences involved include: T1, T2flair, DWI, ADC, SWI, MRA, and high-resolution MRI of the responsible carrier artery (including cross section and longitudinal section). Collect original image images, search for the responsible perforating artery for stroke, calculate baseline core infarct volume (DWI), aggravated core infarct volume (DWI), and final infarct volume (T2 flair) after 2 weeks of treatment. Clinical evaluation baseline and NIHSS score after 3 months, to explore the relationship between responsible blood vessels and core infarct volume and NIHSS score.
- Data statistical methods Measurement data that follow a normal distribution are expressed in the form of mean ± standard deviation, while non normal distribution measurement data are expressed in the form of median (25% percentile -75% percentile). Inter group comparison of econometric data with normal distribution and homogeneity of variance, using t-test or analysis of variance; The Wilcoxon rank sum test is used for inter group comparison of non normal distribution econometric data. The chi square test is used for inter group comparison of count data. Correlation analysis uses either Person correlation analysis or Spearman correlation analysis. The consistency test between methodologies was conducted using Kappa test.
- Conditions
- Stroke, Acute
- Keywords
- Perforating artery, Acute stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Offending vessels
The blood vessels that cause stroke
Measured: 5 years
Core infarct volume
The volume of high signal in the infarcted area on DWl or T2 FLAIR
Measured: 5 years
NIH Stroke Scale (NIlSS）
The NIHSS score includes: consciousness level (consciousness level, consciousness level questioning, consciousness level instruction), gaze, field of vision, facial paralysis, upper limb movement, lower limb movement, limb ataxia, sensation, language, articulation disorders, and neglect. The scoring range is 0-42 points, with higher scores indicating more severe neurological damage
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170086
- Sponsor's protocol ID
- brain acute ischemic stroke
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Neurological Trajectory and Clinical Outcomes in Brain Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06170086
- Acronym / sponsor ID
- brain acute ischemic stroke
- Conditions
- Stroke, Acute
- Keywords
- Perforating artery, Acute stroke
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 14 Dec 2023 (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.
Prospective identification of potential responsible blood vessels, provision of intervention targets, prevention of fatal and disabling cerebrovascular diseases, identification of early END patients, determination of clinical treatment pathways, improvement of efficacy, and improvement of prognosis
Detailed description
- Research background： Stroke is divided into ischemic stroke and hemorrhagic stroke, with ischemic stroke accounting for about 70% and being the main type of stroke. The branch atherosclerotic disease (BAD) accounts for 10%~15% of all acute ischemic stroke (ALS), mainly involving lenticular artery (LSA), parapontine median artery (PPA), thalamic geniculate body artery, anterior choroidal artery Heubner's artery and thalamic perforating artery. Its clinical symptoms often manifest as early neurological deterioration (END), mainly progressive motor dysfunction (PDM), within 48 to 72 hours of onset, with an incidence rate of approximately 17% -75%. The clinical prognosis is poor.
- The purpose and significance of the research Prospective identification of potential responsible blood vessels, provision of intervention targets, prevention of fatal and disabling cerebrovascular diseases, identification of early END patients, determination of clinical treatment pathways, improvement of efficacy, and improvement of prognosis
- Research contents 1) Research on the relationship between stroke responsibility vessels and the pathogenesis of END in patients based on magnetic resonance three-dimensional time leap vascular imaging technology; 2) The impact of clinical interventions (intravenous thrombolysis, antiplatelet therapy, anticoagulation, statins, neuroprotective drugs, etc.) on END
- Patient inclusion and exclusion criteria inclusion criteria
- Acute perforating atherosclerotic stroke patients within 48 hours of onset;
- Age ≥ 18 years and ≤ 80 years old;
- Having two or more vascular risk factors, including hypertension, diabetes, coronary heart disease, hyperlipidemia, smoking and obesity;
- Sign informed consent form exclusion criteria <!-- -->
- Patients with large artery stroke;
- Contraindications to magnetic resonance imaging or pregnant women;
- Other vascular lesions, such as aneurysms, vascular dissection, vasculitis, and brain tumors
- Research method Select and treat emergency stroke patients according to the research design requirements, record clinical data, and evaluate the timing of 7T MRI. The patient underwent 7T MRI examination within 24 hours after the first diagnosis of acute stroke of the perforating artery, within 24 hours after aggravation, and 2 weeks after treatment according to the consensus of Chinese experts on perforating artery atherosclerosis. The sequences involved include: T1, T2flair, DWI, ADC, SWI, MRA, and high-resolution MRI of the responsible carrier artery (including cross section and longitudinal section). Collect original image images, search for the responsible perforating artery for stroke, calculate baseline core infarct volume (DWI), aggravated core infarct volume (DWI), and final infarct volume (T2 flair) after 2 weeks of treatment. Clinical evaluation baseline and NIHSS score after 3 months, to explore the relationship between responsible blood vessels and core infarct volume and NIHSS score.
- Data statistical methods Measurement data that follow a normal distribution are expressed in the form of mean ± standard deviation, while non normal distribution measurement data are expressed in the form of median (25% percentile -75% percentile). Inter group comparison of econometric data with normal distribution and homogeneity of variance, using t-test or analysis of variance; The Wilcoxon rank sum test is used for inter group comparison of non normal distribution econometric data. The chi square test is used for inter group comparison of count data. Correlation analysis uses either Person correlation analysis or Spearman correlation analysis. The consistency test between methodologies was conducted using Kappa test.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A. Acute Perforating artery stroke patients within 48 hours of onset; B. Age ≥ 18 years and ≤ 80 years old; C. Have two or more vascular risk factors, including hypertension, diabetes, coronary heart disease, hyperlipidemia, smoking and obesity; D. Sign an informed consent form;
Key inclusion criteria (1 listed)
- Acute Perforating artery stroke patients within 48 hours of onset; B. Age ≥ 18 years and ≤ 80 years old; C. Have two or more vascular risk factors, including hypertension, diabetes, coronary heart disease, hyperlipidemia, smoking and obesity; D. Sign an informed consent form;
Key exclusion criteria (1 listed)
- Patients with large artery stroke; B. Contraindications to magnetic resonance imaging or pregnant women; C. Other vascular lesions, such as aneurysms, vascular dissection, vasculitis, and brain tumors;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Offending vessels
Time frame: 5 years
The blood vessels that cause stroke
Core infarct volume
Time frame: 5 years
The volume of high signal in the infarcted area on DWl or T2 FLAIR
NIH Stroke Scale (NIlSS）
Time frame: 5 years
The NIHSS score includes: consciousness level (consciousness level, consciousness level questioning, consciousness level instruction), gaze, field of vision, facial paralysis, upper limb movement, lower limb movement, limb ataxia, sensation, language, articulation disorders, and neglect. The scoring range is 0-42 points, with higher scores indicating more severe neurological damage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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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.
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, Acute, run by Chinese PLA General Hospital 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 14 Dec 2023. 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?
This study is still under way. Results are not available in the source record yet.
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?
Offending vessels (time frame: 5 years). The study lists 3 primary outcomes in all. 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 14 Dec 2023.