Cerebrovascular StrokeCASCASNCT05028855
Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis
An observational study of Cerebrovascular Stroke and Cerebral Artery Stenosis, run by Yi Yang at 1 site in China.
Trial summary
In this multi-center prospective observational study within a cohort of symptomatic cerebral atherosclerotic stenosis (sCAS) patients, 850 subjects were planed to be enrolled to explore the relationship between cerebral autoregulation (CA) and stroke recurrence, determine the threshold values of CA parameter for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Stroke, Cerebral Artery Stenosis
- What is being tested?
- Cerebral autoregulation assessment
- How many people
- 850 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2017to 30 Aug 2026
- How long will I take part?
- 24 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of symptomatic cerebral atherosclerotic stenosis, were recruited according to Inclusion Criteria, mostly from the First Hospital of Jilin University, and partly from other hospitals.
Who may be able to join
- Age ranging from 18 to 80, both genders
- Unilateral internal carotid artery (ICA) or M1 segment of middle cerebral artery (MCA) stenosis (rate of stenosis ranging from 50-99%)
- Acute ischemic cerebrovascular events (TIA or ischemic stroke) within cerebral stenotic artery supplying area
- Onset of disease <30 d before enrollment
- Modified Ranking Scale (mRS) ≤1 before stroke onset
- National Institutes of Health Stroke Scale (NIHSS) ≤20
Show all 9Show fewer
- Sufficient bilateral temporal bone windows for insonation of the middle cerebral artery
- Be conscious, and able to cooperate with CA assessment
- Willing to participate and sign the informed consent
Who cannot join
- Vertebral artery (VA), basilar artery (BA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) stenosis; Bilateral internal carotid artery (ICA) or M1 segment of middle cerebral artery (MCA) stenosis(rate of stenosis ranging from 50-99%)
- Patients who have received or plan to undergo intravascular interventional treatment/endarterectomy
- Other intracranial diseases, including cerebral hemorrhage (primary or secondary), intracranial neoplasm, aneurysm, arteriovenous malformation, etc.
- Evidence for embolic stroke, such as atrial fibrillation, prosthetic valve surgery, and suspected endocarditis, etc.
- Arrhythmia, anemia and hyperthyroidism which may influence the stability of cerebral blood flow diagnosed by two physicians by electrocardiogram and laboratory tests.
- Dementia, severe anxiety, depression, and other mental diseases
- Malignant neoplasm and expected lifetime <2 years
- Enrolled in other clinical trails within 6 months
Trial locations and contacts
1 site in 1 country.
Zhenni Guo, MD contact
China1 site, 1 recruiting
- Recruiting
the First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang
About this study
In this multi-center prospective observational study within a cohort of symptomatic cerebral atherosclerotic stenosis (sCAS) patients, 850 subjects were planed to be enrolled to explore the relationship between cerebral autoregulation (CA) and stroke recurrence, determine the threshold values of CA parameter for predicting stroke recurrence associated with particular stenosis.
Read the detailed description
Ischemic stroke is a tremendous public health burden that seriously endangers the health of Chinese population symptomatic cerebral atherosclerotic stenosis (sCAS) is responsible for about 33-50% of ischemic stroke in China and highly associated with the risk of stroke recurrence.
Cerebral autoregulation (CA) is the main protective mechanism that modulates cerebral blood flow to satisfy regional cerebral perfusion demands despite of variations in arterial blood pressure (ABP). Thus, CA supposed to be particularly considered when choosing individual therapeutic strategy in sCAS patients. In clinical practice, applying transcranial Doppler combined with servo-controlled plethysmograph assessing CA has been proved a feasible method in cerebral atherosclerotic stenosis patients. Especially in those severe stenosis patients, CA is probably compromised in varying degrees, whereas whether and to what extent CA parameters have the capability to predict stroke recurrence has not been illustrated.
Thus, the aim of the study was to assess CA after acute ischemic stroke or transient ischemic attack within 2 years follow-up to explore the relationship between CA and stroke recurrence and determine the threshold values of CA parameter to predict stroke recurrence. CA measurement will be performed at 0-3 and 10-30 days after ischemic cerebrovascular events. Clinical information, neuroimaging data, biochemical examinations and follow-up information will be collected and recorded in case report form (CRF) once signing of informed consent.
- Conditions
- Cerebrovascular Stroke, Cerebral Artery Stenosis
- Being tested
- Cerebral autoregulation assessment
- Keywords
- cerebral atherosclerotic stenosis, ischemic stroke, transient ischemic attack, cerebral autoregulation
- Medical subject headings
- Stroke, Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral autoregulation assessmentDiagnostic test
Cerebral autoregulation assessment will be conducted by specialized neurovascular ultrasound doctors during 0-3 and 10-30 days after stroke onset.The recorded data will be stored for further cerebral autoregulation analysis.
| Study group | Role | What they receive |
|---|---|---|
| sCAS patients | Investigators plan to enroll 850 patients of symptomatic cerebral atherosclerotic stenosis (sCAS) for cerebral autoregulation assessment to explore the relationship between cerebral autoregulation (CA) and stroke recurrence, determine the threshold values of CA parameter for predicting stroke recurrence associated with particular stenosis. Receives: Diagnostic Test: Cerebral autoregulation assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke recurrence rate
Ischemic cerebrovascular recurrence (TIA or ischemic stroke) within cerebral stenotic artery supplying area diagnosed by symptoms and imaging examinations.
Measured: two years
Secondary outcomes (6)
The index of cerebral autoregulation
Phase difference, gain and coherence of symptomatic cerebral atherosclerotic stenosis patients within 30 days ischemic cerebrovascular events onset.
Measured: within 30 days ischemic cerebrovascular events onset
ischemic cerebrovascular recurrence rate
All ischemic cerebrovascular recurrence (TIA or ischemic stroke) within two years follow-up diagnosed by symptoms and imaging examinations.
Measured: two years
The first onset time of composite endpoint events within 2 years
The composite endpoint events include fatal and nonfatal stroke (ischemic or hemorrhagic stroke), fatal and nonfatal myocardial infarction, transient ischemic attack (TIA) diagnosed by symptoms and imaging examinations.
Measured: two years follow-up
mRS and Barthel score
The changes of mRS and Barthel score within 2 years
Measured: two years
The first onset time of each individual part of composite endpoint events within 2 years
The first onset time of each individual part of composite endpoint events within 2 years
Measured: two years follow-up
the NIHSS score
The changes of NIHSS score from admission to discharge
Measured: within 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start14 Jan 2017
- Primary completion24 Dec 2025 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular StrokeStudies of the same condition, open and under way.
- 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
- 850 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of University of South China, Eighth Affiliated Hospital, Sun Yat-sen University, The First Affiliated Hospital of Hebei North University, Qilu Hospital of Shandong University, The Affiliated Hospital of Qingdao University, The Affiliated Hospital of Yanbian University
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
- Investigators
- Yi Yang, MD, PhD, Study chair, Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028855
- Sponsor's protocol ID
- CASCAS
- Acronym
- CASCAS
- Status last verified
- Feb 2024
- First submitted
- 19 Jul 2017
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis
- ClinicalTrials.gov ID
- NCT05028855
- Acronym / sponsor ID
- CASCAS / CASCAS
- Conditions
- Cerebrovascular Stroke, Cerebral Artery Stenosis
- Keywords
- cerebral atherosclerotic stenosis, ischemic stroke, transient ischemic attack, cerebral autoregulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of University of South China, Eighth Affiliated Hospital, Sun Yat-sen University, The First Affiliated Hospital of Hebei North University, Qilu Hospital of Shandong University, The Affiliated Hospital of Qingdao University, The Affiliated Hospital of Yanbian University
- Study start
- 14 Jan 2017 (actual)
- Primary completion
- 24 Dec 2025 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 31 Aug 2021 (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.
In this multi-center prospective observational study within a cohort of symptomatic cerebral atherosclerotic stenosis (sCAS) patients, 850 subjects were planed to be enrolled to explore the relationship between cerebral autoregulation (CA) and stroke recurrence, determine the threshold values of CA parameter for predicting stroke recurrence associated with particular stenosis.
Detailed description
Ischemic stroke is a tremendous public health burden that seriously endangers the health of Chinese population symptomatic cerebral atherosclerotic stenosis (sCAS) is responsible for about 33-50% of ischemic stroke in China and highly associated with the risk of stroke recurrence.
Cerebral autoregulation (CA) is the main protective mechanism that modulates cerebral blood flow to satisfy regional cerebral perfusion demands despite of variations in arterial blood pressure (ABP). Thus, CA supposed to be particularly considered when choosing individual therapeutic strategy in sCAS patients. In clinical practice, applying transcranial Doppler combined with servo-controlled plethysmograph assessing CA has been proved a feasible method in cerebral atherosclerotic stenosis patients. Especially in those severe stenosis patients, CA is probably compromised in varying degrees, whereas whether and to what extent CA parameters have the capability to predict stroke recurrence has not been illustrated.
Thus, the aim of the study was to assess CA after acute ischemic stroke or transient ischemic attack within 2 years follow-up to explore the relationship between CA and stroke recurrence and determine the threshold values of CA parameter to predict stroke recurrence. CA measurement will be performed at 0-3 and 10-30 days after ischemic cerebrovascular events. Clinical information, neuroimaging data, biochemical examinations and follow-up information will be collected and recorded in case report form (CRF) once signing of informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sCAS patients | – | Diagnostic Test: Cerebral autoregulation assessmentInvestigators plan to enroll 850 patients of symptomatic cerebral atherosclerotic stenosis (sCAS) for cerebral autoregulation assessment to explore the relationship between cerebral autoregulation (CA) and stroke recurrence, determine the threshold values of CA parameter for predicting stroke recurrence associated with particular stenosis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of symptomatic cerebral atherosclerotic stenosis, were recruited according to Inclusion Criteria, mostly from the First Hospital of Jilin University, and partly from other hospitals.
Key inclusion criteria (9 listed)
- Age ranging from 18 to 80, both genders
- Unilateral internal carotid artery (ICA) or M1 segment of middle cerebral artery (MCA) stenosis (rate of stenosis ranging from 50-99%)
- Acute ischemic cerebrovascular events (TIA or ischemic stroke) within cerebral stenotic artery supplying area
- Onset of disease <30 d before enrollment
- Modified Ranking Scale (mRS) ≤1 before stroke onset
Key exclusion criteria (8 listed)
- Vertebral artery (VA), basilar artery (BA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) stenosis; Bilateral internal carotid artery (ICA) or M1 segment of middle cerebral artery (MCA) stenosis(rate of stenosis ranging from 50-99%)
- Patients who have received or plan to undergo intravascular interventional treatment/endarterectomy
- Other intracranial diseases, including cerebral hemorrhage (primary or secondary), intracranial neoplasm, aneurysm, arteriovenous malformation, etc.
- Evidence for embolic stroke, such as atrial fibrillation, prosthetic valve surgery, and suspected endocarditis, etc.
- Arrhythmia, anemia and hyperthyroidism which may influence the stability of cerebral blood flow diagnosed by two physicians by electrocardiogram and laboratory tests.
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 |
|---|---|---|
| Cerebral autoregulation assessmentCerebral autoregulation assessment will be conducted by specialized neurovascular ultrasound doctors during 0-3 and 10-30 days after stroke onset.The recorded data will be stored for further cerebral autoregulation analysis. | Diagnostic test | sCAS patients |
Primary outcome
Stroke recurrence rate
Time frame: two years
Ischemic cerebrovascular recurrence (TIA or ischemic stroke) within cerebral stenotic artery supplying area diagnosed by symptoms and imaging examinations.
6 secondary outcomes
The index of cerebral autoregulation
Time frame: within 30 days ischemic cerebrovascular events onset
ischemic cerebrovascular recurrence rate
Time frame: two years
The first onset time of composite endpoint events within 2 years
Time frame: two years follow-up
mRS and Barthel score
Time frame: two years
The first onset time of each individual part of composite endpoint events within 2 years
Time frame: two years follow-up
the NIHSS score
Time frame: within 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 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.
Zhenni Guo, MD contact
Yi Yang, MD, PhD study chair
Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
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 Cerebrovascular Stroke and Cerebral Artery Stenosis, run by Yi Yang 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 9 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: status not confirmed, as of the sponsor's last update on 1 Mar 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 Yi Yang, MD, PhD (0086-13756661217, doctor_yangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke recurrence rate (time frame: two years). 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 1 Mar 2024.