UltrasoundNCT05849909
Evaluation of the Vulnerable Carotid Atherosclerotic Plaque: A Clinical Multicenter Study
An observational study of Ultrasound, run by huang pintong at 1 site in China.
Trial summary
Evaluation of carotid plaque vulnerability based on ultrasound imaging features, proteomics and metabolomics: a clinical multicenter study Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ultrasound
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2023to 18 Apr 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing carotid endarterectomy
Who may be able to join
- Patients who meet the CEA surgical indications;
- Age>18 years old;
- Patients who sign informed consent forms
Who cannot join
- Those with severe calcification of plaques and obvious acoustic shadows, and poor image quality;
- Contraindications to ultrasound contrast, such as those who are allergic to contrast agents;
- Intracardiac right to left shunt;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Pintong Huang, +8618857168333, huangpintong@126.com
About this study
Evaluation of carotid plaque vulnerability based on ultrasound imaging features, proteomics and metabolomics: a clinical multicenter study
Read the detailed description
Carotid artery plaque tissue specimen for proteomics. Blood were collect for metabolomics.
- Conditions
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stable Carotid Atherosclerotic Plaques | Not described | |
| Unstable Carotid Atherosclerotic Plaques | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound
B mode
Measured: 2023.05
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start18 Apr 2023
- Primary completion20 Apr 2023
- Study completion18 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- huang pintong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, huang pintong, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849909
- Sponsor's protocol ID
- 2023-0402
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Vulnerable Carotid Atherosclerotic Plaque: A Clinical Multicenter Study
- ClinicalTrials.gov ID
- NCT05849909
- Acronym / sponsor ID
- 2023-0402
- Conditions
- Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- huang pintongUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 18 Apr 2024 (estimated)
- First posted
- 9 May 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.
Evaluation of carotid plaque vulnerability based on ultrasound imaging features, proteomics and metabolomics: a clinical multicenter study
Detailed description
Carotid artery plaque tissue specimen for proteomics. Blood were collect for metabolomics.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stable Carotid Atherosclerotic Plaques | – | – |
| Unstable Carotid Atherosclerotic Plaques | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing carotid endarterectomy
Key inclusion criteria (3 listed)
- Patients who meet the CEA surgical indications;
- Age>18 years old;
- Patients who sign informed consent forms
Key exclusion criteria (3 listed)
- Those with severe calcification of plaques and obvious acoustic shadows, and poor image quality;
- Contraindications to ultrasound contrast, such as those who are allergic to contrast agents;
- Intracardiac right to left shunt;
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
ultrasound
Time frame: 2023.05
B mode
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- 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. This study is not recruiting at the moment.
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
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 Ultrasound, run by huang pintong 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 3 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 9 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasound (time frame: 2023.05). 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 9 May 2023.