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

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.

Study Overview

• Status: Unknown
• Conditions: Carotid Stenosis; Carotid Endarterectomy
• Intervention / Treatment: Diagnostic test: Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP

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 Type: Observational
• Enrollment (Anticipated): 272

Contacts and Locations

• Study Contact: Name: Joao R Neves, MD, MSC; MPH; Phone Number: +351910486230; Email: joaorochaneves@hotmail.com

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Faculdade de Medicina da Universidade do Porto
    • Contact: Departamento FMUP; Phone Number: (+351) 22 551 3600; Email: fmup@med.up.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients selected and submited to carotid endarterectomy under regional anesthesia

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Diagnostic test: Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP; peak wave velocity; gray weale plaque classification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Investigators: Principal Investigator: Joao R Neves, MD, MSC, MPH, Universidade do Porto

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: 250-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No