Carotid Artery StenosisRECASNCT06031610
Revascularization Effect on CSVD Burden in Carotid Artery Stenosis
An observational study of Carotid Artery Stenosis and Cerebral Small Vessel Diseases, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
RECAS is a prospective cohort of 1,000 patients with carotid artery stenosis (CAS) and undergoing revascularization therapy or standard medication treatment alone. The goal of this study is to validate whether CAS revascularization when compared to standard medication treatment alone, can effectively reduce the… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Carotid Artery Stenosis, Cerebral Small Vessel Diseases
- What is being tested?
- carotid artery stenting and drug therapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2023to May 2034
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The research population for this study consists of patients who have been diagnosed with Carotid Artery Stenosis. The inclusion criteria are: Patients aged ≥ 40 years，≥ 50% stenosis in unilateral carotid artery,sign informed consent.The exclusion criteria are: Previous history of major head trauma and any intracranial surgery,intracranial abnormalities,extrapyramidal symptoms or mental illness which may affect neuropsychological measurement,severe loss of vision, hearing, or communicative ability. The patients will be recruited from Zhejiang Provincial People's Hospital in the city of Hangzhou.
Who may be able to join
- Patients aged ≥ 40 years.
- ≥ 50% stenosis in unilateral carotid artery.
- Sign informed consent.
Who cannot join
- Previous history of major head trauma and any intracranial surgery
- Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage, and other space occupying lesions
- Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement.
- Severe loss of vision, hearing, or communicative ability.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000
Sheng Zhang, MD, +8618758188313 ext. 0571-85893472, zhangsheng@hmc.edu.cn
Sheng Zhang, M.D.
About this study
RECAS is a prospective cohort of 1,000 patients with carotid artery stenosis (CAS) and undergoing revascularization therapy or standard medication treatment alone. The goal of this study is to validate whether CAS revascularization when compared to standard medication treatment alone, can effectively reduce the progression of Cerebral small vessel disease (CSVD) burden, as well as improve the severity of retinal pathologies and cognitive impairment. Therefore, Patients aged ≥ 40 years have more than 50% stenosis in unilateral carotid artery and sign informed consent will be recruited. In this study, patients will be asked to undergo Computed Tomography Angiography (CTA)/ Digital Subtraction Angiography (DSA), Computed Tomography Perfusion (CTP),multimodal Magnetic Resonance Imaging (MRI), Optical Coherence Tomography Angiography (OCTA) and neuropsychological testing. Estimated follow-up can be up to 10 years.
- Being tested
- carotid artery stenting, drug therapy
- Keywords
- Carotid Artery Stenosis, Cerebral Small Vessel Diseases, Revascularization, Carotid artery stenting, prospective cohort
- Medical subject headings
- Carotid Stenosis, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid artery stentingProcedure or surgery
Patients were monitored for at least 24 h after surgery, with control for hyperperfusion syndrome, dual antiplatelet therapy was continued for 4-6 weeks, and the postoperative patients have the final residual stenosis of less than 30%, thrombolysis in Myocardial Infarction (TIMI) grade 3, and no dissection or thrombosis. Any surgery-related complications were recorded.
drug therapyDrug
Carotid artery stenosis requires taking antiplatelet aggregation drugs and statin lipid-lowering drugs. It can inhibit platelet aggregation, stabilize plaque, reduce vascular inflammatory factors, and prevent further development of atherosclerosis.
| Study group | Role | What they receive |
|---|---|---|
| Individuals accepted CAS | Procedure: CAS and Standard medical treatment.
Other:
1. Neuropsychological testing.
2. Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA.
3. Multimodal MRI included T1, T2-FLAIR, DWI, DTI, SWI, fMRI.
4. Optical coherence tomography angiography. Receives: Procedure: carotid artery stenting; Drug: drug therapy | |
| Individuals accepted standard medical treatment alone. | Procedure: Standard medical treatment alone.
Other:
1. Neuropsychological testing.
2. Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA.
3. Multimodal MRI includedT1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI.
4. Optical coherence tomography angiography. Receives: Drug: drug therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of total brain small vessel disease burden in MRI
Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points.
Measured: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Secondary outcomes (9)
Montreal Cognitive Assessment (MoCA) score
To assess changes in cognitive function of patients.
Measured: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Mini-mental State Examination(MMSE) score
To assess changes in cognitive function of patients.
Measured: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Blood flow density
Record blood flow density (%) of OCTA.
Measured: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Vascular perfusion area
Record vascular perfusion area (mm^2) of OCTA.
Measured: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Macular fovea retinal thickness
Record macular fovea retinal thickness (μm) of OCTA.
Measured: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Retinal nerve fiber layer thickness
Record retinal nerve fiber layer thickness (μm) of OCTA.
Measured: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Change of the volume of hypoperfusion (delay time>3s from baseline to follow-up CTP).
Change of the volume of delay time>3s in follow-up minus the volume at baseline.
Measured: baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Stenosis percent
Restenosis can be identified by CTA/DSA evaluating the percentage of lumen of vessel but can also be classified as symptomatic vs asymptomatic and/or requiring or not re-intervention.
Measured: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Number of Patients with cerebrovascular events, cardiovascular events or death
Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and cerebral hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.
Measured: baseline,1-month,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start10 Jun 2023
- Primary completionDec 2033 (estimated)
- Study completionMay 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosisStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031610
- Sponsor's protocol ID
- ZJPPHEC2023O（290）
- Acronym
- RECAS
- Status last verified
- Oct 2024
- First submitted
- 21 Aug 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duering M, Biessels GJ, Brodtmann A, Chen C, Cordonnier C, de Leeuw FE, Debette S, Frayne R, Jouvent E, Rost NS, Ter Telgte A, Al-Shahi Salman R, Backes WH, Bae HJ, Brown R, Chabriat H, De Luca A, deCarli C, Dewenter A, Doubal FN, Ewers M, Field TS, Ganesh A, Greenberg S, Helmer KG, Hilal S, Jochems ACC, Jokinen H, Kuijf H, Lam BYK, Lebenberg J, MacIntosh BJ, Maillard P, Mok VCT, Pantoni L, Rudilosso S, Satizabal CL, Schirmer MD, Schmidt R, Smith C, Staals J, Thrippleton MJ, van Veluw SJ, Vemuri P, Wang Y, Werring D, Zedde M, Akinyemi RO, Del Brutto OH, Markus HS, Zhu YC, Smith EE, Dichgans M, Wardlaw JM. Neuroimaging standards for research into small vessel disease-advances since 2013. Lancet Neurol. 2023 Jul;22(7):602-618. doi: 10.1016/S1474-4422(23)00131-X. Epub 2023 May 23.
PubMed 37236211
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revascularization Effect on CSVD Burden in Carotid Artery Stenosis
- ClinicalTrials.gov ID
- NCT06031610
- Acronym / sponsor ID
- RECAS / ZJPPHEC2023O（290）
- Keywords
- Carotid Artery Stenosis, Cerebral Small Vessel Diseases, Revascularization, Carotid artery stenting, prospective cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- Dec 2033 (estimated)
- Study completion
- May 2034 (estimated)
- First posted
- 11 Sep 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.
RECAS is a prospective cohort of 1,000 patients with carotid artery stenosis (CAS) and undergoing revascularization therapy or standard medication treatment alone. The goal of this study is to validate whether CAS revascularization when compared to standard medication treatment alone, can effectively reduce the progression of Cerebral small vessel disease (CSVD) burden, as well as improve the severity of retinal pathologies and cognitive impairment. Therefore, Patients aged ≥ 40 years have more than 50% stenosis in unilateral carotid artery and sign informed consent will be recruited. In this study, patients will be asked to undergo Computed Tomography Angiography (CTA)/ Digital Subtraction Angiography (DSA), Computed Tomography Perfusion (CTP),multimodal Magnetic Resonance Imaging (MRI), Optical Coherence Tomography Angiography (OCTA) and neuropsychological testing. Estimated follow-up can be up to 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals accepted CAS | – | Procedure: carotid artery stenting, Drug: drug therapyProcedure: CAS and Standard medical treatment. Other: 1. Neuropsychological testing. 2. Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA. 3. Multimodal MRI included T1, T2-FLAIR, DWI, DTI, SWI, fMRI. 4. Optical coherence tomography angiography. |
| Individuals accepted standard medical treatment alone. | – | Drug: drug therapyProcedure: Standard medical treatment alone. Other: 1. Neuropsychological testing. 2. Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA. 3. Multimodal MRI includedT1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI. 4. Optical coherence tomography angiography. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The research population for this study consists of patients who have been diagnosed with Carotid Artery Stenosis. The inclusion criteria are: Patients aged ≥ 40 years，≥ 50% stenosis in unilateral carotid artery,sign informed consent.The exclusion criteria are: Previous history of major head trauma and any intracranial surgery,intracranial abnormalities,extrapyramidal symptoms or mental illness which may affect neuropsychological measurement,severe loss of vision, hearing, or communicative ability. The patients will be recruited from Zhejiang Provincial People's Hospital in the city of Hangzhou.
Key inclusion criteria (3 listed)
- Patients aged ≥ 40 years.
- ≥ 50% stenosis in unilateral carotid artery.
- Sign informed consent.
Key exclusion criteria (4 listed)
- Previous history of major head trauma and any intracranial surgery
- Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage, and other space occupying lesions
- Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement.
- Severe loss of vision, hearing, or communicative ability.
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 |
|---|---|---|
| carotid artery stentingPatients were monitored for at least 24 h after surgery, with control for hyperperfusion syndrome, dual antiplatelet therapy was continued for 4-6 weeks, and the postoperative patients have the final residual stenosis of less than 30%, thrombolysis in Myocardial Infarction (TIMI) grade 3, and no dissection or thrombosis. Any surgery-related complications were recorded. | Procedure or surgery | Individuals accepted CAS |
| drug therapyCarotid artery stenosis requires taking antiplatelet aggregation drugs and statin lipid-lowering drugs. It can inhibit platelet aggregation, stabilize plaque, reduce vascular inflammatory factors, and prevent further development of atherosclerosis. | Drug | Individuals accepted CAS, Individuals accepted standard medical treatment alone. |
Primary outcome
The development of total brain small vessel disease burden in MRI
Time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points.
9 secondary outcomes
Montreal Cognitive Assessment (MoCA) score
Time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Mini-mental State Examination(MMSE) score
Time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Blood flow density
Time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Vascular perfusion area
Time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Macular fovea retinal thickness
Time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Retinal nerve fiber layer thickness
Time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Change of the volume of hypoperfusion (delay time>3s from baseline to follow-up CTP).
Time frame: baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Stenosis percent
Time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Number of Patients with cerebrovascular events, cardiovascular events or death
Time frame: baseline,1-month,3-month,6-month,and every 1 year, follow-up time up to 10 years.
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 12 Feb 2025.
- Background: PubMed 37236211Duering M, Biessels GJ, Brodtmann A, Chen C, Cordonnier C, de Leeuw FE, Debette S, Frayne R, Jouvent E, Rost NS, Ter Telgte A, Al-Shahi Salman R, Backes WH, Bae HJ, Brown R, Chabriat H, De Luca A, deCarli C, Dewenter A, Doubal FN, Ewers M, Field TS, Ganesh A, Greenberg S, Helmer KG, Hilal S, Jochems ACC, Jokinen H, Kuijf H, Lam BYK, Lebenberg J, MacIntosh BJ, Maillard P, Mok VCT, Pantoni L, Rudilosso S, Satizabal CL, Schirmer MD, Schmidt R, Smith C, Staals J, Thrippleton MJ, van Veluw SJ, Vemuri P, Wang Y, Werring D, Zedde M, Akinyemi RO, Del Brutto OH, Markus HS, Zhu YC, Smith EE, Dichgans M, Wardlaw JM. Neuroimaging standards for research into small vessel disease-advances since 2013. Lancet Neurol. 2023 Jul;22(7):602-618. doi: 10.1016/S1474-4422(23)00131-X. Epub 2023 May 23.
- Related InfoLink provided by the sponsor.
- 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.
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 Carotid Artery Stenosis and Cerebral Small Vessel Diseases, run by Zhejiang Provincial People's 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 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 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?
Contact Sheng Zhang, M.D. (+8618758188313, zhangsheng@hmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The development of total brain small vessel disease burden in MRI (time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06031610, which also lists 1 linked publication.
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 Feb 2025.