Carotid Artery PlaqueNCT02820207
Identification of Carotid Plague Vulnerability by Contrast Enhanced Ultrasound: Correlation With Plague Histopathology
An observational study of Carotid Artery Plaque and Ultrasonic Diagnosis, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
OBJECTIVE/BACKGROUND: Intraplaque neovascularization is one of the most important risk factors for unstable carotid plaque. This study was designed to evaluate whether carotid intraplaque neovascularization (IPN) can be accurately assessed by contrast enhanced ultrasound (CEUS). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Carotid Artery Plaque, Ultrasonic Diagnosis
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2016to 30 Jun 2020
- How long will I take part?
- 6 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients suffering from carotid artery stenosis
Who may be able to join
- The patients with ischemic symptom whose carotid stenosis were more than 50%
- The patients without ischemic symptom whose carotid stenosis were more than 70%
Who cannot join
- Confirmed with severe intracranial vascular lesions
- Suffering from the large area cerebral infarction or critical stroke sequela
- Restenosis after CEA or CAS
- Suffering from severe coronary heart disease, respiratory failure,the hypertension difficult to controled
- Patients with malignant tumor or expected life < 2 years
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tsinghua Chang Gung Hosipital
Beijing, Beijing Municipality, 102218
About this study
Official title: Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital
OBJECTIVE/BACKGROUND: Intraplaque neovascularization is one of the most important risk factors for unstable carotid plaque. This study was designed to evaluate whether carotid intraplaque neovascularization (IPN) can be accurately assessed by contrast enhanced ultrasound (CEUS).
METHODS: Preoperative CEUS analysis of 50 carotid artery stenosis patients would be compared to histopathology performed on their plaques excised by carotid endarterectomy (CEA) with CD34 and MMP9 staining.
Read the detailed description
- To enroll 50 cases of patients suffering from carotid artery stenosis continuously, the investigators perform contrast enhanced ultrasound on patients for identifying the vulnerable plagues and taking high resolution MR inspection to analysis those plagues at the same time.
- All patients undergo carotid endarterectomy. The vulnerable ingredients of carotid plaques such as intraplaque neovascularization and bleeding are identified by pathological examination and immunohistochemical staining.
- To evaluate the accuracy of CEUS for identifying carotid vulnerable plague compared with high resolution MR.
- The investigators divide patients into the stable group and the vulnerable group based on the results of CEUS inspection. To analysis the incidence of postoperative complications such as stroke and mortality within 30 days and to compare the differences between the two groups.
- Conditions
- Carotid Artery Plaque, Ultrasonic Diagnosis
- Keywords
- Carotid Artery Plaque, Contrast Enhanced Ultrasound, Plague Histopathology
- Medical subject headings
- Carotid Stenosis
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 |
|---|---|---|
| Vulnerable plague | The patients suffering from carotid artery stenosis were identified as the vulnerable plague group by Contrast Enhanced Ultrasound whose plagues were found intraplaque neovascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of ischemia shock
The incidence of ischemic stroke was defined as the number of cases of postoperative cerebral infarction divided by the total number of cases
Measured: within 30 days after operations
Secondary outcomes (2)
the incidence of restenosis
the loss of lumen of carotid beyond 70% is defined as restenosis
Measured: 6 months after operations
the incidence of all-cause mortality
All-cause mortality includes all causes of death, such as MI, heart failure, stroke, bleeding et al.
Measured: within 30 days after operations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start13 Jan 2016
- Primary completion30 Nov 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery PlaqueStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung 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
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keqiang Zhao, Beijing Tsinghua Chang Gung Hospital
- Investigators
- sifan Yang, M.D., Study director, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820207
- Sponsor's protocol ID
- （2016）003
- Status last verified
- Jul 2020
- First submitted
- 20 Jun 2016
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital
- ClinicalTrials.gov ID
- NCT02820207
- Acronym / sponsor ID
- （2016）003
- Conditions
- Carotid Artery Plaque, Ultrasonic Diagnosis
- Keywords
- Carotid Artery Plaque, Contrast Enhanced Ultrasound, Plague Histopathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 30 Jun 2016 (estimated)
- 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.
OBJECTIVE/BACKGROUND: Intraplaque neovascularization is one of the most important risk factors for unstable carotid plaque. This study was designed to evaluate whether carotid intraplaque neovascularization (IPN) can be accurately assessed by contrast enhanced ultrasound (CEUS).
METHODS: Preoperative CEUS analysis of 50 carotid artery stenosis patients would be compared to histopathology performed on their plaques excised by carotid endarterectomy (CEA) with CD34 and MMP9 staining.
Detailed description
- To enroll 50 cases of patients suffering from carotid artery stenosis continuously, the investigators perform contrast enhanced ultrasound on patients for identifying the vulnerable plagues and taking high resolution MR inspection to analysis those plagues at the same time.
- All patients undergo carotid endarterectomy. The vulnerable ingredients of carotid plaques such as intraplaque neovascularization and bleeding are identified by pathological examination and immunohistochemical staining.
- To evaluate the accuracy of CEUS for identifying carotid vulnerable plague compared with high resolution MR.
- The investigators divide patients into the stable group and the vulnerable group based on the results of CEUS inspection. To analysis the incidence of postoperative complications such as stroke and mortality within 30 days and to compare the differences between the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vulnerable plague | – | –The patients suffering from carotid artery stenosis were identified as the vulnerable plague group by Contrast Enhanced Ultrasound whose plagues were found intraplaque neovascularization |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients suffering from carotid artery stenosis
Key inclusion criteria (2 listed)
- The patients with ischemic symptom whose carotid stenosis were more than 50%
- The patients without ischemic symptom whose carotid stenosis were more than 70%
Key exclusion criteria (5 listed)
- Confirmed with severe intracranial vascular lesions
- Suffering from the large area cerebral infarction or critical stroke sequela
- Restenosis after CEA or CAS
- Suffering from severe coronary heart disease, respiratory failure,the hypertension difficult to controled
- Patients with malignant tumor or expected life < 2 years
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
the incidence of ischemia shock
Time frame: within 30 days after operations
The incidence of ischemic stroke was defined as the number of cases of postoperative cerebral infarction divided by the total number of cases
2 secondary outcomes
the incidence of restenosis
Time frame: 6 months after operations
the incidence of all-cause mortality
Time frame: within 30 days after operations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- 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. This study is not recruiting at the moment.
sifan Yang, M.D. study director
Beijing Tsinghua Chang Gung Hospital
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 Plaque and Ultrasonic Diagnosis, run by Beijing Tsinghua Chang Gung 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 5 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: finished, as of the sponsor's last update on 1 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the incidence of ischemia shock (time frame: within 30 days after operations). 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 Feb 2021.