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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04327492
Other study ID # 250-19
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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