Hemathologic and Imagiologic Predictors of Stroke During Carotid Endarterectomy With Regional Anesthesia
Clinical, Hematological, and Imagiologic Predictors of Postoperative Complications and Long Term Cardiovascular Events After Carotid Endarterectomy With Regional Anesthesia
1 other identifier
observational
272
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2020
CompletedFirst Posted
Study publicly available on registry
March 31, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 31, 2020
March 1, 2020
1.8 years
March 26, 2020
March 26, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Stroke
30 days, long-term
Clavien dindo>3
30 days, long-term
MACE
AMI, stroke, Major adverse limb event, acute hear faillure hospitalization, all cause mortality
30 days, long-term
Study Arms (1)
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
Interventions
peak wave velocity; gray weale plaque classification
Eligibility Criteria
Patients selected and submited to carotid endarterectomy under regional anesthesia
You may qualify if:
- \- consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) under regional anesthesia
You may not qualify if:
- general anesthesia
- carotid stenting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculdade de Medicina da Universidade do Porto
Porto, 4200-319, Portugal
Biospecimen
blood sample. atherosclerotic plaque
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joao R Neves, MD, MSC, MPH
Universidade do Porto
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSC; MPH, FEBVS
Study Record Dates
First Submitted
March 26, 2020
First Posted
March 31, 2020
Study Start
April 1, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
March 31, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share