Hemathologic and Imagiologic Predictors of Stroke During Carotid Endarterectomy With Regional Anesthesia

• Conditions: Carotid Stenosis; Carotid Endarterectomy
• Interventions: Diagnostic Test: Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP

• Registration Number: NCT04327492
• Lead Sponsor: Universidade do Porto

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.

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 Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Last Update Submitted: 2020-03-26
• Study First Posted: 2020-03-31
• Last Update Posted: 2020-03-31
• Study Start: 2020-04-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

• consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) under regional anesthesia

Exclusion Criteria

• general anesthesia
• carotid stenting

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carotid endarterectomy	Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP	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

Primary Outcome Measures

Name	Time	Method
Stroke	30 days, long-term
Clavien dindo>3	30 days, long-term
MACE	30 days, long-term	AMI, stroke, Major adverse limb event, acute hear faillure hospitalization, all cause mortality

Trial Locations

Locations (1)

Faculdade de Medicina da Universidade do Porto; 🇵🇹 Porto, Portugal