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

Stroke Clinical Trial

— IMPROVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03218527
• Other study ID #: IIBSP-ATE-2015-38
• Status: Recruiting
• Phase: N/A
• First received: July 5, 2017
• Last updated: July 12, 2017
• Start date: October 1, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Pol Camps-Remom, MD
• Phone: +34660030907
• Email: pcamps[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Inflammation
• Stroke

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

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