CClinicalTrials.gg
Status unknownNCT03218527IMPROVEUpdated Jul 14, 2017

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

An observational study in Atherosclerosis, Stroke and Inflammation, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-14.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Atherosclerosis
  • Stroke
  • Inflammation
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In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 265 are open to participants now.

This study's planned enrollment of 120 is below the median of 223 across 571 observational studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and at one year follow-up

  2. 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

    Time frame: Baseline and at one year follow-up

  3. Change in the Endothelial Progenitor Cells Count

    Change in the Endothelial Progenitor Cells Count by flow cytometry

    Time frame: Baseline and at one year follow-up

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Study locations

1 of 1 sites recruiting
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 08025, Spain
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03218527
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Instituto de Salud Carlos III
Responsible party
Sponsor
First posted
Jul 14, 2017
Start date
Oct 1, 2015
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Jul 14, 2017

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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