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

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ClinicalTrials.gov Identifier: NCT03218527
Recruitment Status : Unknown
Verified July 2017 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
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

Condition or disease
Atherosclerosis Stroke Inflammation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Influence of Circulating Endothelial Progenitor Cells and Modifiable Vascular Risk Factors on Carotid Plaque Vulnerability
Study Start Date : October 1, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018



Primary Outcome Measures :
  1. Change in the Standardized Uptake Value (SUV) of the internal carotid artery [ Time Frame: 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

  2. Change in the Target-to-Background Ratio (TBR) of the internal carotid artery [ Time Frame: 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

  3. Change in the Endothelial Progenitor Cells Count [ Time Frame: Baseline and at one year follow-up ]
    Change in the Endothelial Progenitor Cells Count by flow cytometry



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients diagnosed of ischemic stroke presenting at least on atherosclerotic plaque in the internal carotid artery ipsilateral to stroke
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218527


Contacts
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Contact: Pol Camps-Remom, MD +34660030907 pcamps@santpau.cat

Locations
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Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Pol Camps-Renom, MD    +34660030907    pcamps@santpau.cat   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Instituto de Salud Carlos III

Additional Information:

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03218527     History of Changes
Other Study ID Numbers: IIBSP-ATE-2015-38
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atherosclerosis
Inflammation
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases