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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP | Diagnostic Test | peak wave velocity; gray weale plaque classification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stroke | 30 days, long-term | |
| Clavien dindo>3 | 30 days, long-term | |
| MACE | AMI, stroke, Major adverse limb event, acute hear faillure hospitalization, all cause mortality | 30 days, long-term |
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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:
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Patients selected and submited to carotid endarterectomy under regional anesthesia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joao R Neves, MD, MSC; MPH | Contact | +351910486230 | joaorochaneves@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Joao R Neves, MD, MSC, MPH | Universidade do Porto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de Medicina da Universidade do Porto | Porto | 4200-319 | Portugal |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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blood sample. atherosclerotic plaque
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |