Influence of Circulating Endothelial Progenitor Cells and Modifiable Vascular Risk Factors on Carotid Plaque Vulnerability

• Conditions: Inflammation; Atherosclerosis; Stroke

• Registration Number: NCT03218527
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

Ischemic stroke is a leading cause of death and disability worldwide. Atherosclerosis, responsible for the 20% of ischemic strokes, is characterized by lipid accumulation in the artery wall that leads to chronic inflammation, cell proliferation and ultimately to vessel stenosis. One of the main features related to plaque progression and vulnerability is inflammation. Positron emission tomography with 18-fluorodeoxyglucos (18-FDG PET) allows an accurate quantification of plaque inflammation and it has been proved its usefulness in predicting early stroke recurrences. The investigators aim to test how modifiable vascular risk factors influence plaque inflammation assessed by 18-FDG PET. In addition, investigators will assess the association of this inflammation and circulating endothelial progenitor cells

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-12
• Last Update Submitted: 2017-07-12
• Study First Posted: 2017-07-14
• Last Update Posted: 2017-07-14
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Ischemic stroke within 7 days before inclusion
• At least one atherosclerotic plaque in the internal carotid artery
• >18 years old

Exclusion Criteria

• Cardioembolic strokes according to TOAST criteria
• Poor functional outcome (Rankin >3) after stroke

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Endothelial Progenitor Cells Count	Baseline and at one year follow-up	Change in the Endothelial Progenitor Cells Count by flow cytometry
Change in the Standardized Uptake Value (SUV) of the internal carotid artery	Baseline and at one year follow-up	Inflammation change of the internal carotid artery assessed by the Standardized Uptake Value (SUV) obtained with 18FDG-PET scan at one-year follow-up
Change in the Target-to-Background Ratio (TBR) of the internal carotid artery	Baseline and at one year follow-up	Inflammation change of the internal carotid artery assessed by the Target-to-Background Ratio (TBR) obtained with 18FDG-PET scan at one-year follow-up

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain