Carotid EndarterectomyNCT04960488
Multidisciplinary CAE and CABG Surgery to Optimize the Management of High-risk Patients During the Perioperative Period
A study testing carotid endarterectomy and coronary artery bypass grafting in people with Carotid Endarterectomy and Coronary Artery Bypass Grafting, run by Peking University Third Hospital at 1 site in China.
Trial summary
This project uses concurrent CEA+CABG combined surgery on high-risk patients with severe carotid artery stenosis and severe coronary artery stenosis. After multidisciplinary preoperative evaluation, intraoperative electrophysiological monitoring, and postoperative management standards, compare CEA+CABG combined… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carotid Endarterectomy, Coronary Artery Bypass Grafting
- What is being tested?
- carotid endarterectomy and coronary artery bypass grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 30 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- (1) In patients with symptomatic carotid artery stenosis, the preoperative CTA or DSA, combined with carotid ultrasound and high-resolution magnetic resonance clearly diagnosed the degree of carotid artery stenosis on the responsible side>50%; (2) Patients with asymptomatic carotid artery stenosis before operation CTA or DSA, combined with carotid ultrasound and high-resolution magnetic resonance, clearly diagnosed the carotid artery stenosis rate of the affected side>70%; (3) All patients with carotid artery stenosis were located in the surgically accessible position, without complete carotid artery occlusion or intracranial segment Severe vascular stenosis; (4) The stenosis rate of the left main coronary artery by coronary angiography is more than 70%, or the disease of the three main vessels is more than 50%, and the bridging condition is good.
- Exclusion Criteria:(1) The disease is beyond the reach of surgery (such as C2 level or above); (2) The symptoms of hypertension are not effectively controlled before surgery (systolic blood pressure> 180mmHg); (3) Carotid artery stenosis caused by non-atherosclerosis , Such as arteritis, arterial dissection, vascular congenital malformations, etc.; (4) combined with hemorrhagic cerebrovascular diseases such as intracranial aneurysms or vascular malformations; (5) combined with blood system diseases that lead to coagulation dysfunction that cannot be corrected or refused to accept blood and blood Importers of products; (6) Pregnancy or perinatal period.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidisciplinary Collaborative Carotid Endarterectomy and Coronary Artery Bypass Graft Surgery to Optimize the Management of High-risk Patients During the Perioperative Period
This project uses concurrent CEA+CABG combined surgery on high-risk patients with severe carotid artery stenosis and severe coronary artery stenosis. After multidisciplinary preoperative evaluation, intraoperative electrophysiological monitoring, and postoperative management standards, compare CEA+CABG combined operations during the same period And the advantages and disadvantages of a single CABG or CEA operation, the purpose is to explore the best surgical treatment plan, establish an interdisciplinary clinical medicine platform centered on patients with heart and cerebrovascular diseases, and develop a standard procedure and The perioperative management is standard, so it is particularly important and naturally has its advanced significance.
Read the detailed description
This project uses concurrent carotid endarterectomy and coronary artery bypass grafting combined surgery on high-risk patients with severe carotid artery stenosis and severe coronary artery stenosis. After multidisciplinary preoperative evaluation, intraoperative electrophysiological monitoring, and postoperative management standards, compare CEA+CABG combined operations during the same period And the advantages and disadvantages of a single CABG or CEA operation, the purpose is to explore the best surgical treatment plan, establish an interdisciplinary clinical medicine platform centered on patients with heart and cerebrovascular diseases, and develop a standard procedure and The perioperative management is standard, so it is particularly important and naturally has its advanced significance.
- Being tested
- carotid endarterectomy and coronary artery bypass grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid endarterectomy and coronary artery bypass graftingProcedure or surgery
carotid endarterectomy and coronary artery bypass grafting
| Study group | Role | What they receive |
|---|---|---|
| carotid endarterectomy and coronary artery bypass grafting | Experimental | carotid endarterectomy and coronary artery bypass grafting Receives: Procedure: carotid endarterectomy and coronary artery bypass grafting |
| carotid endarterectomy | Active comparator | carotid endarterectomy Receives: Procedure: carotid endarterectomy and coronary artery bypass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral oxygen saturation
Cerebral oxygen saturation monitoring
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Dec 2019
- Primary completion30 Jul 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid EndarterectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- tao wang, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960488
- Sponsor's protocol ID
- M2020062
- Status last verified
- Dec 2019
- First submitted
- 4 Jul 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Collaborative Carotid Endarterectomy and Coronary Artery Bypass Graft Surgery to Optimize the Management of High-risk Patients During the Perioperative Period
- ClinicalTrials.gov ID
- NCT04960488
- Acronym / sponsor ID
- M2020062
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 14 Jul 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.
This project uses concurrent CEA+CABG combined surgery on high-risk patients with severe carotid artery stenosis and severe coronary artery stenosis. After multidisciplinary preoperative evaluation, intraoperative electrophysiological monitoring, and postoperative management standards, compare CEA+CABG combined operations during the same period And the advantages and disadvantages of a single CABG or CEA operation, the purpose is to explore the best surgical treatment plan, establish an interdisciplinary clinical medicine platform centered on patients with heart and cerebrovascular diseases, and develop a standard procedure and The perioperative management is standard, so it is particularly important and naturally has its advanced significance.
Detailed description
This project uses concurrent carotid endarterectomy and coronary artery bypass grafting combined surgery on high-risk patients with severe carotid artery stenosis and severe coronary artery stenosis. After multidisciplinary preoperative evaluation, intraoperative electrophysiological monitoring, and postoperative management standards, compare CEA+CABG combined operations during the same period And the advantages and disadvantages of a single CABG or CEA operation, the purpose is to explore the best surgical treatment plan, establish an interdisciplinary clinical medicine platform centered on patients with heart and cerebrovascular diseases, and develop a standard procedure and The perioperative management is standard, so it is particularly important and naturally has its advanced significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carotid endarterectomy and coronary artery bypass grafting | Experimental | Procedure: carotid endarterectomy and coronary artery bypass graftingcarotid endarterectomy and coronary artery bypass grafting |
| carotid endarterectomy | Active comparator | Procedure: carotid endarterectomy and coronary artery bypass graftingcarotid endarterectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- (1) In patients with symptomatic carotid artery stenosis, the preoperative CTA or DSA, combined with carotid ultrasound and high-resolution magnetic resonance clearly diagnosed the degree of carotid artery stenosis on the responsible side>50%; (2) Patients with asymptomatic carotid artery stenosis before operation CTA or DSA, combined with carotid ultrasound and high-resolution magnetic resonance, clearly diagnosed the carotid artery stenosis rate of the affected side>70%; (3) All patients with carotid artery stenosis were located in the surgically accessible position, without complete carotid artery occlusion or intracranial segment Severe vascular stenosis; (4) The stenosis rate of the left main coronary artery by coronary angiography is more than 70%, or the disease of the three main vessels is more than 50%, and the bridging condition is good.
- Exclusion Criteria:(1) The disease is beyond the reach of surgery (such as C2 level or above); (2) The symptoms of hypertension are not effectively controlled before surgery (systolic blood pressure> 180mmHg); (3) Carotid artery stenosis caused by non-atherosclerosis , Such as arteritis, arterial dissection, vascular congenital malformations, etc.; (4) combined with hemorrhagic cerebrovascular diseases such as intracranial aneurysms or vascular malformations; (5) combined with blood system diseases that lead to coagulation dysfunction that cannot be corrected or refused to accept blood and blood Importers of products; (6) Pregnancy or perinatal period.
- -
Key exclusion criteria (0 listed)
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 endarterectomy and coronary artery bypass graftingcarotid endarterectomy and coronary artery bypass grafting | Procedure or surgery | carotid endarterectomy, carotid endarterectomy and coronary artery bypass grafting |
Primary outcome
Cerebral oxygen saturation
Time frame: Intraoperative
Cerebral oxygen saturation monitoring
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 14 Jul 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.
tao wang study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carotid endarterectomy and coronary artery bypass grafting in people with Carotid Endarterectomy and Coronary Artery Bypass Grafting, run by Peking University Third 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 0 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 14 Jul 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?
Cerebral oxygen saturation (time frame: Intraoperative). 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 14 Jul 2021.