Unrupturiertes zerebrales Aneurysma: Vorhersage der Evolution (U-CAN)
The protocol has many assets. A prospective nationwide recruitment allows for the inclusion of a large cohort of patients with UIA. It will combine accurate clinical phenotyping and comprehensive imaging with CAWE screening. Besides, it will enable to exploit metadata and to explore new pathophysiological pathways of interest by crossing clinical, genetic, biological, and imaging information.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Management of small (<7mm) unruptured intracranial aneurysms (UIA) remains controversial. Previous retrospective studies have suggested that post gadolinium arterial wall enhancement (AWE) of unruptured intracranial aneurysms on MR imaging may reflect aneurysm wall instability, and hence may highlight a higher risk of UIA growth over time. This multicentric prospective cohort aims at exploring vessel wall imaging findings of UIAs with consecutive follow-up to substantiate these assumptions.The objective is to develop diagnostic and predictive tools for the risk of IA evolution. The aim is to demonstrate in clinical practice the predictive value of (AWE) for UIA growth. The growth will be determined by any modification of the UIA measurement. Both UIA growth and the UIA wall enhancement will be assessed in consensus by two expert neuroradiologists.The French prospective UCAN project is a non-interventional international wide and multicentric prospective cohort. UIA of bifurcation between 3 and 7 mm for whom a clinical and imaging follow-up without occlusion treatment was scheduled by local multidisciplinary staff will be included. Extensive clinical, biological and imaging data will be recorded during a 3 years follow-up (visits at 1 and 3 years after inclusion).
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Romain BOURCIER, MD
- Telefonnummer: 33240165608
- E-Mail: romain.bourcier@chu-nantes.fr
Studienorte
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Besançon, Frankreich
- Rekrutierung
- CHU de Besançon
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Hauptermittler:
- Alessandra BIONDI
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Kontakt:
- Alessandra BIONDI
- Telefonnummer: +33 3 81 66 81 66
- E-Mail: biondi.alessandra@gmail.com
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Caen, Frankreich
- Rekrutierung
- CHU de Caen
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Kontakt:
- Charlotte BARBIER
- Telefonnummer: +33 2 31 06 31 06
- E-Mail: barbier-ch@chu-caen.fr
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Hauptermittler:
- Charlotte BARBIER
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Clermont-Ferrand, Frankreich
- Rekrutierung
- CHU de Clermont Ferrand
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Kontakt:
- Emmanuel CHABERT
- Telefonnummer: +33 4 73 751 747
- E-Mail: echabert@chu-clermontferrand.fr
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Hauptermittler:
- Emmanuel CHABERT
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Colmar, Frankreich
- Noch keine Rekrutierung
- Hôpitaux Civils de Colmar
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Kontakt:
- Pablo Ariel LEBEDINSKY, MD
- Telefonnummer: +33 3.89.12.44.39
- E-Mail: pablo.lebedinsky@ch-colmar.fr
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Hauptermittler:
- Pablo Ariel LEBEDINSKY
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Dijon, Frankreich
- Rekrutierung
- CHU Dijon
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Kontakt:
- Pierre THOUANT
- Telefonnummer: +33 3 80 29 30 31
- E-Mail: pierrethouant@gmail.com
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Hauptermittler:
- Pierre THOUANT
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Poitiers, Frankreich
- Rekrutierung
- CHU de Poitiers
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Hauptermittler:
- Samy BOUCEBCI
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Kontakt:
- Samy BOUCEBCI
- Telefonnummer: +33 5 49 44 44 44
- E-Mail: Samy.BOUCEBCI@chu-poitiers.fr
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Saint-Etienne, Frankreich
- Rekrutierung
- CHU de saint Etienne
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Hauptermittler:
- Marina SACHET
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Kontakt:
- Marina SACHET
- Telefonnummer: +33 4 77 82 80 00
- E-Mail: Marina.Sachet@chu-st-etienne.fr
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Strasbourg, Frankreich
- Rekrutierung
- CHU de Strasbourg
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Hauptermittler:
- Raoul POP
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Kontakt:
- Raoul POP
- Telefonnummer: +33 3 88 11 67 68
- E-Mail: raoul.pop@chru-strasbourg.fr
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Suresnes, Frankreich
- Rekrutierung
- Hôpital Foch
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Hauptermittler:
- Arturo CONSOLI
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Kontakt:
- Arturo CONSOLI
- Telefonnummer: +33 1 46 25 20 00
- E-Mail: a.consoli@hopital-foch.com
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Toulon, Frankreich
- Rekrutierung
- St Anne HIA
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Kontakt:
- Quentin Holay
- E-Mail: qholay@gmail.com
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Frankreich, 13000
- Rekrutierung
- Clairval's Hospital
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Finistère
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Brest, Finistère, Frankreich, 29200
- Rekrutierung
- Brest University Hospital
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Gironde
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Bordeaux, Gironde, Frankreich, 33000
- Rekrutierung
- Bordeaux University Hospital
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankreich, 31000
- Rekrutierung
- Toulouse University Hospital
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Haute-Vienne
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Limoges, Haute-Vienne, Frankreich, 87000
- Rekrutierung
- Limoges University Hospital
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Frankreich, 35000
- Rekrutierung
- Rennes University Hospital
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Indre-et-Loire
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Tours, Indre-et-Loire, Frankreich, 37000
- Rekrutierung
- Tours University Hospital
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Loire-Atlantique
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Nantes, Loire-Atlantique, Frankreich, 44000
- Rekrutierung
- Nantes University Hospital
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Hauptermittler:
- Romain BOURCIER, MD
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Maine et Loire
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Angers, Maine et Loire, Frankreich, 49000
- Rekrutierung
- Angers University Hospital
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Marne
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Reims, Marne, Frankreich, 51100
- Zurückgezogen
- Reims University Hospital
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Meurthe-et-Moselle
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Nancy, Meurthe-et-Moselle, Frankreich, 54000
- Rekrutierung
- Nancy University Hospital
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Paris
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Paris, Paris, Frankreich, 75000
- Rekrutierung
- AP-HP La Pitié-Salpêtrière Hospital
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Paris, Paris, Frankreich, 75000
- Rekrutierung
- AP-HP Le Kremlin Bicêtre Hospital
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Paris, Paris, Frankreich, 75000
- Rekrutierung
- Rostchild Foundation Hospital
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Seine-Maritime
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Rouen, Seine-Maritime, Frankreich, 76000
- Rekrutierung
- Rouen University Hospital
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Somme
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Amiens, Somme, Frankreich, 80000
- Rekrutierung
- Amiens University Hospital
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Île-de-France Region
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Paris, Île-de-France Region, Frankreich, 75674
- Rekrutierung
- Ste Anne's Hospital
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Utrecht, Niederlande, 3500
- Abgeschlossen
- UMC Utrecht
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Bern, Schweiz, 3000
- Noch keine Rekrutierung
- InselHospital Bern
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
The recruited population is composed of subjects carrying unruptured asymptomatic typical IA of bifurcation for whom a clinical, a biological and an imaging follow-up, without occlusion treatment, was scheduled by local multidisciplinary staff.
Beschreibung
Inclusion Criteria :
- Subject carrying unruptured, asymptomatic and untreated typical IA of bifurcation, measured on conventional imaging (MRI, CTA or DSA) between 3 and 7 mm of larger diameter.
- Ability to be followed-up during 3 years decided in consensus multidisciplinary gathering.
- Age > 18 years old.
Exclusion Criteria :
- A failure to obtain informed consent
- Contraindications for undergoing an MRI scan include : (heart pacemaker, a metallic foreign body (metal sliver) in their eye, or aneurysm clip in their brain, severe claustrophobia)
- Contraindications for a gadolinium contrast medium injection (:eGFR below 30 mL/min/1.73 m2, Previous or pre-existing nephrogenic systemic fibrosis, Previous anaphylactic/anaphylactoid reaction to gadolinium containing contrast agent, Acutely deteriorating renal function, Pregnancy and breast-feeding)
- A mycotic, fusiform-shaped, or dissecting IA, an IA in relation with an arteriovenous malformation
- A family history of polycystic kidney disease, Ehlers-Danlos syndrome, Marfan's syndrom, fibromuscular dysplasia, or Moya Moya disease
- Intra-cavernous UIA because the sinus cavernous that is fulfilled with venous blood precluded a reliable assessment of aneurysmal wall enhancement (AWE)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The aim is to evaluate in clinical practice the predictive value of UIA wall enhancement for UIA growth. It will allow to set up a secure, efficient and personalized follow-up.
Zeitfenster: 5 years
|
In order to evaluate the informative value of AWE for UIA growth, investigators will consider as primary endpoint the growth of the UIA after the complete follow-up at 3 years. |
5 years
|
|
Predictive value of UIA wall enhancement for UIA growth
Zeitfenster: at 1 year
|
This event could occur at any time during the follow-up if an UIA becomes symptomatic but will be systematically assessed by MRI. UIA growth will be assessed blindly and independently by two expert neuroradiologists, routinely involved in UIA management and disagreement will be solved by consensus with involvement of a third expert. UIA wall enhancement status will be defined independently by two different expert neuroradiologists, with > 5yrs experience in intracranial vessel wall imaging. Disagreement will be solved by consensus with involvement of a third expert. |
at 1 year
|
|
Predictive value of UIA wall enhancement for UIA growth
Zeitfenster: at 3 years
|
This event could occur at any time during the follow-up if an UIA becomes symptomatic but will be systematically assessed by MRI. UIA growth will be assessed blindly and independently by two expert neuroradiologists, routinely involved in UIA management and disagreement will be solved by consensus with involvement of a third expert. UIA wall enhancement status will be defined independently by two different expert neuroradiologists, with > 5yrs experience in intracranial vessel wall imaging. Disagreement will be solved by consensus with involvement of a third expert. |
at 3 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Quality of life related to the growth of UIA.
Zeitfenster: 5 years
|
Evaluation of the quality of life (QOL) of untreated patients with UIA during the follow-up. |
5 years
|
|
AWE variation patterns related to the growth of UIA.
Zeitfenster: 5 years
|
Detection of other AWE variation patterns related to growth during the follow-up in order to improve the follow-up of UIA patients |
5 years
|
|
Clinical, genetics or biological factors related to the growth of UIA.
Zeitfenster: 5 years
|
Clinical, genetic (blood serum level of circulating ANGPTL6) and biological (plasma factors as circulating ANGPTL6 levels, metalloproteinase…) features recorded. |
5 years
|
|
Incidence of growth of UIA.
Zeitfenster: 5 years
|
Incidence of growth, stratified by clinical, genetics or biological features. |
5 years
|
|
Incidence of IA rupture
Zeitfenster: 5 years
|
Incidence of IA rupture, stratified by clinical, genetics or biological features. |
5 years
|
|
quality of life patients related to the growth of UIA.
Zeitfenster: 5 years
|
Completion of standardized EQ5D questionnaire to measure quality of life patients |
5 years
|
|
Construction of an automatized tool of AWE pattern
Zeitfenster: 5 years
|
Construction and evaluation of an automatized tool of AWE patterns, as compared to the visual analysis of experts, in the form of a decision-making tool. |
5 years
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Romain BOURCIER, MD, Nantes University Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- RC20_0012
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