- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05623293
Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis
Prognostic Predictors of Cardiovascular and Ophthalmologic Outcomes in Patients With Carotid Artery Stenosis Undergoing Carotid Endarterectomy With Regional Anesthesia - A Prospective Study
Study Overview
Status
Intervention / Treatment
Detailed Description
The authors hypothesize that FGF-23, GDF-15, VEGF-A, MMP-9 and retinal/choroidal microvascular density could predict cerebral ischemia, postoperative complications, long term major cardiovascular events and short term ophthalmologic alterations particularly in patients developing symptomatic neurologic ischemia after circulation shutdown.
The purpose of this study is to compare different cardiac risk scores in carotid endarterectomy. The main aim of this study is to test the risk factors individually and determine its discriminatory ability. Combinations of traditional preoperative risk factors and scores will be evaluated to enhance the assessment of major adverse cardiac events in vascular surgery patients.
Establish and validate biomarkers that improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Joao Rocha-Neves, MD, MPH
- Phone Number: +351910486230
- Email: joaorochaneves@hotmail.com
Study Locations
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-
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Porto, Portugal, 4200-319
- Recruiting
- Joao Rocha-Neves
-
Contact:
- Joao Rocha-Neves
- Phone Number: 910486230
- Email: joaorochaneves@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Consecutive carotid stenosis
Exclusion Criteria:
- blind patients
- Radic stenosis
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Carotid endarterectomy
he population corresponds to patients submitted to elective CEA.
Consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) under regional anesthesia will be prospectively recruited from September 2021 - December 2022.
The expected patient follow-up will be of 2years.
|
pre and postoperative
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke
Time Frame: 30 days
|
diagnosed by Computer tomography and clinical examation
|
30 days
|
optical coherence tomography - Angio
Time Frame: 15 days before surgery
|
Vessel density and distribution
|
15 days before surgery
|
optical coherence tomography - Angio
Time Frame: 24h after surgery
|
Vessel density and distribution
|
24h after surgery
|
optical coherence tomography - Angio
Time Frame: 30 days after surgery
|
Vessel density and distribution
|
30 days after surgery
|
optical coherence tomography - Angio
Time Frame: one year after surgery
|
Vessel density and distribution
|
one year after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Restenosis
Time Frame: 2 months
|
ultrasound defined - internacal carotid Velocity superior to 180 cm/s; or 250 cm/s
|
2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Eye Diseases
- Pathological Conditions, Anatomical
- Uveal Diseases
- Retinal Diseases
- Carotid Stenosis
- Carotid Artery Diseases
- Constriction, Pathologic
- Atherosclerosis
- Choroid Diseases
Other Study ID Numbers
- 163-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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