Carotid StenosisNCT04327492
Hemathologic and Imagiologic Predictors of Stroke During Carotid Endarterectomy With Regional Anesthesia
An observational study of Carotid Stenosis and Carotid Endarterectomy, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Carotid Stenosis, Carotid Endarterectomy
- What is being tested?
- Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP
- How many people
- 272 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2020to 31 Dec 2022
- How long will I take part?
- 5 Years
- 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 18 to 99 years
- All sexes
- Adult, Older adult
Study population: Patients selected and submited to carotid endarterectomy under regional anesthesia
Who may be able to join
- consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) under regional anesthesia
Who cannot join
- general anesthesia
- carotid stenting
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Medicina da Universidade do Porto
Porto, 4200-319
Departamento FMUP, (+351) 22 551 3600, fmup@med.up.pt
About this study
Official title: Clinical, Hematological, and Imagiologic Predictors of Postoperative Complications and Long Term Cardiovascular Events After Carotid Endarterectomy With Regional Anesthesia
Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.
Read the detailed description
The authors hypothesize FGF-23 and GDF-15 could predict cerebral ischemia, postoperative complications and long term major cardiovascular events, particularly in patients developing symptomatic neurologic ischemia after circulation shutdown.
Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.
Clarify the pathophysiology of carotid endarterectomy-related stroke and the role of GDF-15, FGF-23, BNP and hs-troponin I and other biomarkers in the prognosis of symptomatic carotid stenosis.
Imagiologic markers are to be included - intima-media; gray weale plaque classification, cerebral CT Peak wave velocity
- Conditions
- Carotid Stenosis, Carotid Endarterectomy
- Being tested
- Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNPDiagnostic test
peak wave velocity; gray weale plaque classification
| Study group | Role | What they receive |
|---|---|---|
| Carotid endarterectomy | This study is a non-interventional prospective cohort study. The population corresponds to patients submitted to CEA under regional anesthesia. Consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) will be prospectively recruited. The expected patient follow-up will be of 5 years.
The demographics will be recorded in a prospective, protected database. Blood samples will be collected in clot activator serum tubes at three timepoints: timepoint 1 - before surgery (until 15 days before surgery); timepoint 2 up to 48h postoperatively; timepoint Receives: Diagnostic Test: Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke
Measured: 30 days, long-term
Clavien dindo>3
Measured: 30 days, long-term
MACE
AMI, stroke, Major adverse limb event, acute hear faillure hospitalization, all cause mortality
Measured: 30 days, long-term
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (estimated)
- Target duration
- 5 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
- Investigators
- Joao R Neves, MD, MSC, MPH, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327492
- Sponsor's protocol ID
- 250-19
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Hematological, and Imagiologic Predictors of Postoperative Complications and Long Term Cardiovascular Events After Carotid Endarterectomy With Regional Anesthesia
- ClinicalTrials.gov ID
- NCT04327492
- Acronym / sponsor ID
- 250-19
- Conditions
- Carotid Stenosis, Carotid Endarterectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 31 Mar 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.
Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.
Detailed description
The authors hypothesize FGF-23 and GDF-15 could predict cerebral ischemia, postoperative complications and long term major cardiovascular events, particularly in patients developing symptomatic neurologic ischemia after circulation shutdown.
Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.
Clarify the pathophysiology of carotid endarterectomy-related stroke and the role of GDF-15, FGF-23, BNP and hs-troponin I and other biomarkers in the prognosis of symptomatic carotid stenosis.
Imagiologic markers are to be included - intima-media; gray weale plaque classification, cerebral CT Peak wave velocity
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid endarterectomy | – | Diagnostic Test: Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNPThis study is a non-interventional prospective cohort study. The population corresponds to patients submitted to CEA under regional anesthesia. Consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) will be prospectively recruited. The expected patient follow-up will be of 5 years. The demographics will be recorded in a prospective, protected database. Blood samples will be collected in clot activator serum tubes at three timepoints: timepoint 1 - before surgery (until 15 days before surgery); timepoint 2 up to 48h postoperatively; timepoint |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients selected and submited to carotid endarterectomy under regional anesthesia
Key inclusion criteria (1 listed)
- consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) under regional anesthesia
Key exclusion criteria (2 listed)
- general anesthesia
- 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 |
|---|---|---|
| Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNPpeak wave velocity; gray weale plaque classification | Diagnostic test | Carotid endarterectomy |
Primary outcome
Stroke
Time frame: 30 days, long-term
Clavien dindo>3
Time frame: 30 days, long-term
MACE
Time frame: 30 days, long-term
AMI, stroke, Major adverse limb event, acute hear faillure hospitalization, all cause mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- 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.
Joao R Neves, MD, MSC, MPH principal investigator
Universidade do Porto
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 Stenosis and 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 1 inclusion and 2 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 31 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joao R Neves, MD, MSC; MPH (+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: 30 days, long-term). The study lists 3 primary outcomes in all. 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 31 Mar 2020.