Carotid Artery StenosisCOAS-CASNCT05629000
Optimization Strategy of Carotid Artery Stenosis
An observational study of Carotid Artery Stenosis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about how to utilize multiple evaluation techniques in carotid artery stenosis patients for optimizing assessment of diagnosis and treatment strategy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Carotid revascularization, MRI-PWI and CTA
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 Dec 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Mild to severe carotid stenosis or near-occlusion patients receiving carotid revascularization treatment.
Who may be able to join
- patients with severe stenosis (≥50%) or near-occlusion diagnosed by computed tomographic angiogram;
- patients received carotid endarterectomy at Peking Union Medical College Hospital
Who cannot join
- Any contraindication to image examination; (3) refuse to sign the Informed consent.
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
vascular surgery department of PUMCH
Beijing, Beijing Municipality, 100730
Zhichao Lai, MD, 01069152500, zhichao_lai@126.com
Bao Liu, MD
About this study
Official title: Cohort of Optimized Assessment Strategy of Carotid Artery Stenosis
The goal of this observational study is to learn about how to utilize multiple evaluation techniques in carotid artery stenosis patients for optimizing assessment of diagnosis and treatment strategy.
The main questions it aims to answer are:
- Identify best strategy that use multi-modal MRI and CT to assess patients' cerebral lesions and perfusion.
- Identify best strategy that use multi-modal MRI, PET-MRI ultrasound and CT to assess components and characters of patients' carotid plaques.
Participants will accept imaging examination before and after surgery. And doctors will collect basic characteristics, imaging results and biological samples of patients for analysis.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Carotid revascularization, MRI-PWI, CTA, PET/MRI, Ultrasound
- Keywords
- carotid artery stenosis, Perfusion, plaque, MRI, CT, PET/MRI, Ultrasound
- Medical subject headings
- Carotid Stenosis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid revascularizationProcedure or surgery
Also called carotid endarterectomy and carotid artery stent
All patients received carotid revascularization surgery at Peking Union Medical College Hospital.
MRI-PWIDiagnostic test
Multi-modal MRI before and after surgery.
CTADiagnostic test
CTA before and after surgery.
PET/MRIDiagnostic test
PET/MRI before surgery.
UltrasoundDiagnostic test
Ultrasound before and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Carotid artery stenosis | patient with carotid artery stenosis Receives: Procedure: Carotid revascularization; Diagnostic Test: MRI-PWI; Diagnostic Test: CTA; Diagnostic Test: PET/MRI; Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke
perioperative stroke
Measured: During hospital stay, usually 7-30 days post operation
cardiac infarction
perioperative cardiac infarction
Measured: During hospital stay, usually 7-30 days post operation
transient ischemic attack
perioperative transient ischemic attack
Measured: During hospital stay, usually 7-30 days post operation
cerebral hyperperfusion syndrome
perioperative cerebral hyperperfusion syndrome
Measured: During hospital stay, usually 7-30 days post operation
death
perioperative death
Measured: During hospital stay, usually 7-30 days post operation
Secondary outcomes (4)
Image characters of MRI
Arterial transit times, cerebral blood flow, plaque characters, etc.
Measured: half year after operation
Image characters of PET/MRI
Diagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis
Measured: half year after operation
Image characters of ultrasound
Diagnostic performance of carotid artery ultrasound for intracranial or carotid atherosclerosis
Measured: half year after operation
Carotid plaque characters
pathology characters of carotid plaque
Measured: half year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Jan 2015
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by Peking Union Medical College 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629000
- Sponsor's protocol ID
- PUMCH-CAS-006
- Acronym
- COAS-CAS
- Status last verified
- Jan 2022
- First submitted
- 10 Apr 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lai Z, Wang C, Liu X, Sun H, Guo Z, Shao J, Li K, Chen J, Wang J, Lei X, Shu K, Feng Y, Kong D, Sun W, Liu B. Characterization of the proteome of stable and unstable carotid atherosclerotic plaques using data-independent acquisition mass spectrometry. J Transl Med. 2024 Mar 7;22(1):247. doi: 10.1186/s12967-023-04723-1.
PubMed 38454421
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Optimized Assessment Strategy of Carotid Artery Stenosis
- ClinicalTrials.gov ID
- NCT05629000
- Acronym / sponsor ID
- COAS-CAS / PUMCH-CAS-006
- Conditions
- Carotid Artery Stenosis
- Keywords
- carotid artery stenosis, Perfusion, plaque, MRI, CT, PET/MRI, Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Nov 2022 (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.
The goal of this observational study is to learn about how to utilize multiple evaluation techniques in carotid artery stenosis patients for optimizing assessment of diagnosis and treatment strategy.
The main questions it aims to answer are:
- Identify best strategy that use multi-modal MRI and CT to assess patients' cerebral lesions and perfusion.
- Identify best strategy that use multi-modal MRI, PET-MRI ultrasound and CT to assess components and characters of patients' carotid plaques.
Participants will accept imaging examination before and after surgery. And doctors will collect basic characteristics, imaging results and biological samples of patients for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid artery stenosis | – | Procedure: Carotid revascularization, Diagnostic Test: MRI-PWI, Diagnostic Test: CTA, Diagnostic Test: PET/MRI, Diagnostic Test: Ultrasoundpatient with carotid artery stenosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Mild to severe carotid stenosis or near-occlusion patients receiving carotid revascularization treatment.
Key inclusion criteria (2 listed)
- patients with severe stenosis (≥50%) or near-occlusion diagnosed by computed tomographic angiogram;
- patients received carotid endarterectomy at Peking Union Medical College Hospital
Key exclusion criteria (1 listed)
- Any contraindication to image examination; (3) refuse to sign the Informed consent.
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 revascularizationAlso: carotid endarterectomy and carotid artery stentAll patients received carotid revascularization surgery at Peking Union Medical College Hospital. | Procedure or surgery | Carotid artery stenosis |
| MRI-PWIMulti-modal MRI before and after surgery. | Diagnostic test | Carotid artery stenosis |
| CTACTA before and after surgery. | Diagnostic test | Carotid artery stenosis |
| PET/MRIPET/MRI before surgery. | Diagnostic test | Carotid artery stenosis |
| UltrasoundUltrasound before and after surgery. | Diagnostic test | Carotid artery stenosis |
Primary outcome
stroke
Time frame: During hospital stay, usually 7-30 days post operation
perioperative stroke
cardiac infarction
Time frame: During hospital stay, usually 7-30 days post operation
perioperative cardiac infarction
transient ischemic attack
Time frame: During hospital stay, usually 7-30 days post operation
perioperative transient ischemic attack
cerebral hyperperfusion syndrome
Time frame: During hospital stay, usually 7-30 days post operation
perioperative cerebral hyperperfusion syndrome
death
Time frame: During hospital stay, usually 7-30 days post operation
perioperative death
4 secondary outcomes
Image characters of MRI
Time frame: half year after operation
Image characters of PET/MRI
Time frame: half year after operation
Image characters of ultrasound
Time frame: half year after operation
Carotid plaque characters
Time frame: half year after operation
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 29 Nov 2022.
- Derived from this study: PubMed 38454421Lai Z, Wang C, Liu X, Sun H, Guo Z, Shao J, Li K, Chen J, Wang J, Lei X, Shu K, Feng Y, Kong D, Sun W, Liu B. Characterization of the proteome of stable and unstable carotid atherosclerotic plaques using data-independent acquisition mass spectrometry. J Transl Med. 2024 Mar 7;22(1):247. doi: 10.1186/s12967-023-04723-1.
- Individual participant dataSharing planned: Undecided
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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, run by Peking Union Medical College 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 2 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: looking for participants now, as of the sponsor's last update on 29 Nov 2022. 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 Zhichao Lai, MD (01069152500, zhichao_lai@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke (time frame: During hospital stay, usually 7-30 days post operation). The study lists 5 primary outcomes in all. 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 NCT05629000, 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 29 Nov 2022.