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

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04327492
• Other study ID #: 250-19
• Status: Not yet recruiting
• Start date: April 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2020
• Source: Universidade do Porto
• Contact: Joao R Neves, MD, MSC; MPH
• Phone: +351910486230
• Email: joaorochaneves[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 272
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carotid Endarterectomy
• Carotid Stenosis

Intervention

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

Locations

Country	Name	City	State
Portugal	Faculdade de Medicina da Universidade do Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke		30 days, long-term
Primary	Clavien dindo>3		30 days, long-term
Primary	MACE	AMI, stroke, Major adverse limb event, acute hear faillure hospitalization, all cause mortality	30 days, long-term