- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02726984
Carotid Plaque Assessment Using 18Fluorine (18F) -Sodium Fluoride Positron Emission Tomography (PET) /MR (CARTIS)
10 juli 2018 uppdaterad av: Hospices Civils de Lyon
Assessment of Symptomatic and Asymptomatic Carotid Plaques Using Hybrid Imaging 18F-sodium Fluoride PET/MR
Carotid plaque can lead to ischemic stroke.
Treatment of asymptomatic carotid plaque, based on degree stenosis, is still controversial.
Beyond the degree of stenosis, the composition of the plaque could reflect the vulnerability and the risk of ipsilateral ischemic stroke.
Identification of new predictive factor of ipsilateral ischemic stroke in patients with carotid plaque could help to screen high risk patients and to guide the treatment.
The aim of the study is to assess 18F-sodium fluoride uptake among carotid plaque in recently symptomatic and asymptomatic patients.
Investigators conduct a pilot case-control study.
Twelve patients (6 recently symptomatic and 6 asymptomatic) with carotid stenosis (≥50% NASCET) will have a 18F-sodium fluoride PET/MR.
Standardized uptake value (SUV) and tissue-to-background ratio (TBR) will be measured among carotid plaques.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
15
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Bron, Frankrike, 69500
- Hospices Civils de Lyon
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria symptomatic patients:
- age>18
- Carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days or asymptomatic
- ability to give informed consent
- affiliation to social security
Exclusion Criteria:
- Modified Rankin score ˃ 3
- Contraindication to MRI
- Renal failure (creatinine clearance by cockcroft ˂ 50 ml / min)
- Pregnancy / Breastfeeding
- Hypersensitivity to the active substance or excipients
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: case
Patients with carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days
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18F-sodium fluoride PET/MR combining 3Tesla (3T) MR and PET producing 127 slices of 2 mm on an axial field of view of 26 cm.
18F-sodium fluoride (2 à 4 megabecquerel/kilogram (MBq/kg)) will be injected 60 min before.
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Experimentell: control
Patients with asymptomatic carotid plaque ≥ 50%
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18F-sodium fluoride PET/MR combining 3Tesla (3T) MR and PET producing 127 slices of 2 mm on an axial field of view of 26 cm.
18F-sodium fluoride (2 à 4 megabecquerel/kilogram (MBq/kg)) will be injected 60 min before.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
Tidsram: during the last 15 days in symptomatic patients
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during the last 15 days in symptomatic patients
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Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%
Tidsram: at day 0 in asymptomatic patients
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at day 0 in asymptomatic patients
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Measure of SUV (standardized uptake value) among carotid plaques ≥ 50%
Tidsram: at day 0 in asymptomatic patients
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at day 0 in asymptomatic patients
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Measure of TBR (tissue-to-background ratio) among carotid plaques ≥ 50%
Tidsram: during the last 15 days in symptomatic patients
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during the last 15 days in symptomatic patients
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of participants with image of lipid-rich necrotic core accounting for more than 50% of the surface of the plate on a 2D section.
Tidsram: during the last 15 days in symptomatic patients
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identification of images of intraplaque hemorrhage (defined as an hyperintense region within the plaque on a T1-weighted sequence), lipid-rich necrotic core (accounting for more than 50% of the surface of the plate on a 2D section), or thinning/rupture of the fibrous cap (identified on a T1-weighted sequence following intravenous gadolinium administration) in High Resolution MRI by two radiologists.
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during the last 15 days in symptomatic patients
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Number of participants with image of intraplaque hemorrhage defined as an hyperintense region within the plaque on T1-weighted sequence.
Tidsram: during the last 15 days in symptomatic patients
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identification of images of intraplaque hemorrhage (defined as an hyperintense region within the plaque on a T1-weighted sequence), lipid-rich necrotic core (accounting for more than 50% of the surface of the plate on a 2D section), or thinning/rupture of the fibrous cap (identified on a T1-weighted sequence following intravenous gadolinium administration) in High Resolution MRI by two radiologists.
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during the last 15 days in symptomatic patients
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Number of participants with image of thinning/rupture of the fibrous cap on a T1-weighted sequence following intravenous gadolinium administration.
Tidsram: during the last 15 days in symptomatic patients
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identification of images of intraplaque hemorrhage (defined as an hyperintense region within the plaque on a T1-weighted sequence), lipid-rich necrotic core (accounting for more than 50% of the surface of the plate on a 2D section), or thinning/rupture of the fibrous cap (identified on a T1-weighted sequence following intravenous gadolinium administration) in High Resolution MRI by two radiologists.
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during the last 15 days in symptomatic patients
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Number of participants with image of lipid-rich necrotic core accounting for more than 50% of the surface of the plate on a 2D section.
Tidsram: at day 0 in asymptomatic patients
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identification of images of intraplaque hemorrhage (defined as an hyperintense region within the plaque on a T1-weighted sequence), lipid-rich necrotic core (accounting for more than 50% of the surface of the plate on a 2D section), or thinning/rupture of the fibrous cap (identified on a T1-weighted sequence following intravenous gadolinium administration) in High Resolution MRI by two radiologists.
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at day 0 in asymptomatic patients
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Number of participants with image of thinning/rupture of the fibrous cap on a T1-weighted sequence following intravenous gadolinium administration.
Tidsram: at day 0 in asymptomatic patients
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identification of images of intraplaque hemorrhage (defined as an hyperintense region within the plaque on a T1-weighted sequence), lipid-rich necrotic core (accounting for more than 50% of the surface of the plate on a 2D section), or thinning/rupture of the fibrous cap (identified on a T1-weighted sequence following intravenous gadolinium administration) in High Resolution MRI by two radiologists.
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at day 0 in asymptomatic patients
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Number of participants with image of intraplaque hemorrhage defined as an hyperintense region within the plaque on T1-weighted sequence.
Tidsram: during the last 15 days in symptomatic patients
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Quantitative assessement of the wall shear stresses (WSS, measured in Pa) and oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D.
An accurate analysis of the hemodynamic environment will be performed using fluid dynamics mathematical models that allow the calculation of hemodynamic stress at the plate (or "wall shear stress" measured in Pascal) and temporal oscillation of the direction of this force (arbitrary units).
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during the last 15 days in symptomatic patients
|
Quantitative assessement of the wall shear stresses (WSS, measured in Pa) along the carotid wall in 3D.
Tidsram: at day 0 in asymptomatic patients
|
Quantitative assessement of the wall shear stresses (WSS, measured in Pa) along the carotid wall in 3D.
An accurate analysis of the hemodynamic environment will be performed using fluid dynamics mathematical models that allow the calculation of hemodynamic stress at the plate (or "wall shear stress" measured in Pascal) and temporal oscillation of the direction of this force (arbitrary units).
|
at day 0 in asymptomatic patients
|
Quantitative assessement of oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D.
Tidsram: at day 0 in asymptomatic patients
|
Quantitative assessement of oscillatory shear indexes (OSI, unitless) along the carotid wall in 3D.
An accurate analysis of the hemodynamic environment will be performed using fluid dynamics mathematical models that allow the calculation of hemodynamic stress at the plate (or "wall shear stress" measured in Pascal) and temporal oscillation of the direction of this force (arbitrary units).
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at day 0 in asymptomatic patients
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Number of participants with histological image of intraplaque hemorrhage, and/or lipid-rich necrotic core and /or thinning/rupture of the fibrous cap in surgical patients.
Tidsram: during the last 15 days in symptomatic patients
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during the last 15 days in symptomatic patients
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Measure of systemic markers of inflammation: Interleukine 1-Beta (IL1-beta), Tumor Necrosis Factor-alpha (TNF-alpha)
Tidsram: at Day 0
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at Day 0
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Norbert NIGHOGHOSSIAN, Pr, Hospices Civils de Lyon
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 januari 2016
Primärt slutförande (Faktisk)
12 december 2017
Avslutad studie (Faktisk)
12 december 2017
Studieregistreringsdatum
Först inskickad
15 december 2015
Först inskickad som uppfyllde QC-kriterierna
29 mars 2016
Första postat (Uppskatta)
4 april 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 juli 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 juli 2018
Senast verifierad
1 juli 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Cerebrovaskulära störningar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Arteriella ocklusiva sjukdomar
- Carotidartärsjukdomar
- Carotisstenos
- Läkemedels fysiologiska effekter
- Antiinfektionsmedel, lokala
- Anti-infektionsmedel
- Skyddsmedel
- Kariostatiska medel
- Listerine
- Fluorider
- Natriumfluorid
Andra studie-ID-nummer
- 69HCL15_0283
- 2015-002327-26 (EudraCT-nummer)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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