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

Sponsor

Universidade do Porto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04327492

Collaborator

(none)

272

Enrollment

Location

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Stenosis Carotid Endarterectomy	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.

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

272 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculdade de Medicina da Universidade do Porto	Porto		Portugal	4200-319

Sponsors and Collaborators

Universidade do Porto

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

João Rocha Neves, MD, MSC; MPH, FEBVS, Universidade do Porto

ClinicalTrials.gov Identifier:

NCT04327492

Other Study ID Numbers:

250-19

First Posted:

Mar 31, 2020

Last Update Posted:

Mar 31, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carotid Stenosis

Study Results

No Results Posted as of Mar 31, 2020