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

NCT ID: NCT04327492

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

272 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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

Conditions

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Carotid Stenosis Carotid Endarterectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP

Intervention Type DIAGNOSTIC_TEST

peak wave velocity; gray weale plaque classification

Interventions

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Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP

peak wave velocity; gray weale plaque classification

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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João Rocha Neves

MD, MSC; MPH, FEBVS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joao R Neves, MD, MSC, MPH

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Locations

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Faculdade de Medicina da Universidade do Porto

Porto, , Portugal

Site Status

Countries

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Portugal

Central Contacts

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Joao R Neves, MD, MSC; MPH

Role: CONTACT

Phone: +351910486230

Email: [email protected]

Facility Contacts

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Departamento FMUP

Role: primary

Other Identifiers

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250-19

Identifier Type: -

Identifier Source: org_study_id