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Clinical Trials/NCT04327492
NCT04327492
Unknown
Not Applicable

Clinical, Hematological, and Imagiologic Predictors of Postoperative Complications and Long Term Cardiovascular Events After Carotid Endarterectomy With Regional Anesthesia

Universidade do Porto1 site in 1 country272 target enrollmentApril 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carotid Stenosis
Sponsor
Universidade do Porto
Enrollment
272
Locations
1
Primary Endpoint
Stroke
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
December 31, 2022
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

João Rocha Neves

MD, MSC; MPH, FEBVS

Universidade do Porto

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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