Carotid EndarterectomyNCT04347785
Predictors of Post-clamping Neurologic Deficits During Carotid Endarterectomy With Regional Anesthesia
An observational study of Carotid Endarterectomy, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Patients undergoing carotid endarterectomy may suffer from neurologic deficits (ND) during the carotid cross-clamping due to cerebral hypoperfusion. An associated risk of postoperative stroke incidence is also well established. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Carotid Endarterectomy
- What is being tested?
- carotid endarterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 206 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2011to 31 Dec 2030
- How long will I take part?
- 10 Years
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post-clamping deficits were defined as any persistent alteration at neurologic examination during the CACC and resistant to hemodynamic adjustment
Who may be able to join
- carotid endarterectomy under regional anesthesia
- Postclamping carotid deficit
Who cannot join
- carotid stenting
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Faculdade de Medicina da Universidade do Porto
Porto, 4200 - 319
DEpartamento FMUP, MD, (+351) 22 551 3600
About this study
Official title: Preoperative, Intraoperative and Postoperative Predictors of Post-clamping Neurologic Deficits During Carotid Endarterectomy With Regional Anesthesia
Patients undergoing carotid endarterectomy may suffer from neurologic deficits (ND) during the carotid cross-clamping due to cerebral hypoperfusion. An associated risk of postoperative stroke incidence is also well established.
The aim of this study is to evaluate the predictive factors associated with ND during CEA performed with RA. The perioperative implications of the ND were also evaluated.
Read the detailed description
Patients undergoing carotid endarterectomy may suffer from neurologic deficits (ND) during the carotid cross-clamping due to cerebral hypoperfusion. An associated risk of postoperative stroke incidence is also well established.
The aim of this study is to evaluate the predictive factors associated with ND during CEA performed with RA. The perioperative implications of the ND were also evaluated.
All consecutive patients from a tertiary referral center who underwent CEA for carotid artery stenosis (CS) and consecutive patients who presented alterations in the neurologic examination after ICA clamping during CEA are selected. The control patients, submitted to the same procedure but with no neurologic alterations, are consecutively selected.
- Conditions
- Carotid Endarterectomy
- Being tested
- carotid endarterectomy
- Keywords
- Carotid Stenosis, regional anesthesia
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid endarterectomyProcedure or surgery
shunt
| Study group | Role | What they receive |
|---|---|---|
| Neurologic deficit | All consecutive patients from a tertiary referral center who underwent CEA for carotid artery stenosis who presented alterations in the neurologic examination after ICA clamping during CEA area selected Receives: Procedure: carotid endarterectomy | |
| control | The control patients are submitted to the same procedure but with no neurologic alterations, are consecutively selected. a 1 to 1 ratio is used Receives: Procedure: carotid endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke
An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.
Measured: up to 5 years
Secondary outcomes (1)
Clavien-Dindo Classification >3
Postoperative event life threatining and requiring surgical, endoscopic or radiological intervention
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Jan 2011
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 206 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Rocha Neves, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347785
- Sponsor's protocol ID
- 248-18
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: after ethics and data manager authorization
Publications
Pereira-Macedo J, Rocha-Neves JP, Dias-Neto MF, Andrade JPV. Prognostic effect of troponin elevation in patients undergoing carotid endarterectomy with regional anesthesia - A prospective study. Int J Surg. 2019 Nov;71:66-71. doi: 10.1016/j.ijsu.2019.09.015. Epub 2019 Sep 19.
PubMed 31542388Vieira-Andrade JD, Rocha-Neves JP, Macedo JP, Dias-Neto MF. Onset of Neurological Deficit During Carotid Clamping With Carotid Endarterectomy Under Regional Anesthesia Is Not a Predictor of Carotid Restenosis. Ann Vasc Surg. 2019 Nov;61:193-202. doi: 10.1016/j.avsg.2019.05.025. Epub 2019 Aug 2.
PubMed 31382007Pereira-Macedo J, Duarte-Gamas L, Pereira-Neves A, de Andrade JJP, Rocha-Neves J. Short-term outcomes after selective shunt during carotid endarterectomy: a propensity score matching analysis. Neurocirugia (Engl Ed). 2024 Mar-Apr;35(2):71-78. doi: 10.1016/j.neucie.2023.07.006. Epub 2023 Sep 9.
PubMed 37696419
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative, Intraoperative and Postoperative Predictors of Post-clamping Neurologic Deficits During Carotid Endarterectomy With Regional Anesthesia
- ClinicalTrials.gov ID
- NCT04347785
- Acronym / sponsor ID
- 248-18
- Conditions
- Carotid Endarterectomy
- Keywords
- Carotid Stenosis, regional anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Apr 2020 (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.
Patients undergoing carotid endarterectomy may suffer from neurologic deficits (ND) during the carotid cross-clamping due to cerebral hypoperfusion. An associated risk of postoperative stroke incidence is also well established.
The aim of this study is to evaluate the predictive factors associated with ND during CEA performed with RA. The perioperative implications of the ND were also evaluated.
Detailed description
Patients undergoing carotid endarterectomy may suffer from neurologic deficits (ND) during the carotid cross-clamping due to cerebral hypoperfusion. An associated risk of postoperative stroke incidence is also well established.
The aim of this study is to evaluate the predictive factors associated with ND during CEA performed with RA. The perioperative implications of the ND were also evaluated.
All consecutive patients from a tertiary referral center who underwent CEA for carotid artery stenosis (CS) and consecutive patients who presented alterations in the neurologic examination after ICA clamping during CEA are selected. The control patients, submitted to the same procedure but with no neurologic alterations, are consecutively selected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurologic deficit | – | Procedure: carotid endarterectomyAll consecutive patients from a tertiary referral center who underwent CEA for carotid artery stenosis who presented alterations in the neurologic examination after ICA clamping during CEA area selected |
| control | – | Procedure: carotid endarterectomyThe control patients are submitted to the same procedure but with no neurologic alterations, are consecutively selected. a 1 to 1 ratio is used |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-clamping deficits were defined as any persistent alteration at neurologic examination during the CACC and resistant to hemodynamic adjustment
Key inclusion criteria (2 listed)
- carotid endarterectomy under regional anesthesia
- Postclamping carotid deficit
Key exclusion criteria (1 listed)
- carotid stenting
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 endarterectomyshunt | Procedure or surgery | Neurologic deficit, control |
Primary outcome
Stroke
Time frame: up to 5 years
An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.
1 secondary outcome
Clavien-Dindo Classification >3
Time frame: 30 days
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 15 Apr 2020.
- Results publication: PubMed 31542388Pereira-Macedo J, Rocha-Neves JP, Dias-Neto MF, Andrade JPV. Prognostic effect of troponin elevation in patients undergoing carotid endarterectomy with regional anesthesia - A prospective study. Int J Surg. 2019 Nov;71:66-71. doi: 10.1016/j.ijsu.2019.09.015. Epub 2019 Sep 19.
- Results publication: PubMed 31382007Vieira-Andrade JD, Rocha-Neves JP, Macedo JP, Dias-Neto MF. Onset of Neurological Deficit During Carotid Clamping With Carotid Endarterectomy Under Regional Anesthesia Is Not a Predictor of Carotid Restenosis. Ann Vasc Surg. 2019 Nov;61:193-202. doi: 10.1016/j.avsg.2019.05.025. Epub 2019 Aug 2.
- Derived from this study: PubMed 37696419Pereira-Macedo J, Duarte-Gamas L, Pereira-Neves A, de Andrade JJP, Rocha-Neves J. Short-term outcomes after selective shunt during carotid endarterectomy: a propensity score matching analysis. Neurocirugia (Engl Ed). 2024 Mar-Apr;35(2):71-78. doi: 10.1016/j.neucie.2023.07.006. Epub 2023 Sep 9.
- Individual participant dataSharing planned: Undecided. after ethics and data manager authorization
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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 Endarterectomy, run by Universidade do Porto at 1 site in Portugal.
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 15 Apr 2020. 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 Portugal. 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 Joao P Rocha-Neves, MD, MSC; MPH, FEBVS (+351910486230, joaorochaneves@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke (time frame: up to 5 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 NCT04347785, which also lists 3 linked publications.
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 15 Apr 2020.