NCT03218527

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

3.3 years

First QC Date

July 5, 2017

Last Update Submit

July 12, 2017

Conditions

AtherosclerosisStrokeInflammation

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Change in the Endothelial Progenitor Cells Count

    Change in the Endothelial Progenitor Cells Count by flow cytometry

    Baseline and at one year follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed of ischemic stroke presenting at least on atherosclerotic plaque in the internal carotid artery ipsilateral to stroke

You may qualify if:

  • At least one atherosclerotic plaque in the internal carotid artery
  • \>18 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Related Publications (1)

  • Garcia E, Camps-Renom P, Puig N, Fernandez-Leon A, Aguilera-Simon A, Benitez-Amaro A, Sole A, Vilades D, Sanchez-Quesada JL, Marti-Fabregas J, Jimenez-Xarrie E, Benitez S, Llorente-Cortes V. Soluble low-density lipoprotein receptor-related protein 1 as a surrogate marker of carotid plaque inflammation assessed by 18F-FDG PET in patients with a recent ischemic stroke. J Transl Med. 2023 Feb 19;21(1):131. doi: 10.1186/s12967-022-03867-w.

    PMID: 36805772DERIVED

MeSH Terms

Conditions

AtherosclerosisStrokeInflammation

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Pol Camps-Remom, MD

CONTACT

+34660030907pcamps@santpau.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 14, 2017

Study Start

October 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

July 14, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)