미파열 뇌동맥류: 진화의 예측 (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.
연구 개요
상세 설명
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).
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Romain BOURCIER, MD
- 전화번호: 33240165608
- 이메일: romain.bourcier@chu-nantes.fr
연구 장소
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Utrecht, 네덜란드, 3500
- 완전한
- UMC Utrecht
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Bern, 스위스, 3000
- 아직 모집하지 않음
- InselHospital Bern
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Besançon, 프랑스
- 모병
- CHU de Besançon
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수석 연구원:
- Alessandra BIONDI
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연락하다:
- Alessandra BIONDI
- 전화번호: +33 3 81 66 81 66
- 이메일: biondi.alessandra@gmail.com
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Caen, 프랑스
- 모병
- CHU de Caen
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연락하다:
- Charlotte BARBIER
- 전화번호: +33 2 31 06 31 06
- 이메일: barbier-ch@chu-caen.fr
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수석 연구원:
- Charlotte BARBIER
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Clermont-Ferrand, 프랑스
- 모병
- CHU de Clermont Ferrand
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연락하다:
- Emmanuel CHABERT
- 전화번호: +33 4 73 751 747
- 이메일: echabert@chu-clermontferrand.fr
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수석 연구원:
- Emmanuel CHABERT
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Colmar, 프랑스
- 아직 모집하지 않음
- Hôpitaux Civils de Colmar
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연락하다:
- Pablo Ariel LEBEDINSKY, MD
- 전화번호: +33 3.89.12.44.39
- 이메일: pablo.lebedinsky@ch-colmar.fr
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수석 연구원:
- Pablo Ariel LEBEDINSKY
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Dijon, 프랑스
- 모병
- CHU Dijon
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연락하다:
- Pierre THOUANT
- 전화번호: +33 3 80 29 30 31
- 이메일: pierrethouant@gmail.com
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수석 연구원:
- Pierre THOUANT
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Poitiers, 프랑스
- 모병
- CHU de Poitiers
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수석 연구원:
- Samy BOUCEBCI
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연락하다:
- Samy BOUCEBCI
- 전화번호: +33 5 49 44 44 44
- 이메일: Samy.BOUCEBCI@chu-poitiers.fr
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Saint-Etienne, 프랑스
- 모병
- CHU de saint Etienne
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수석 연구원:
- Marina SACHET
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연락하다:
- Marina SACHET
- 전화번호: +33 4 77 82 80 00
- 이메일: Marina.Sachet@chu-st-etienne.fr
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Strasbourg, 프랑스
- 모병
- CHU de Strasbourg
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수석 연구원:
- Raoul POP
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연락하다:
- Raoul POP
- 전화번호: +33 3 88 11 67 68
- 이메일: raoul.pop@chru-strasbourg.fr
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Suresnes, 프랑스
- 모병
- Hôpital Foch
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수석 연구원:
- Arturo CONSOLI
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연락하다:
- Arturo CONSOLI
- 전화번호: +33 1 46 25 20 00
- 이메일: a.consoli@hopital-foch.com
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Toulon, 프랑스
- 모병
- St Anne HIA
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연락하다:
- Quentin Holay
- 이메일: qholay@gmail.com
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, 프랑스, 13000
- 모병
- Clairval's Hospital
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Finistère
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Brest, Finistère, 프랑스, 29200
- 모병
- Brest University Hospital
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Gironde
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Bordeaux, Gironde, 프랑스, 33000
- 모병
- Bordeaux University Hospital
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Haute-Garonne
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Toulouse, Haute-Garonne, 프랑스, 31000
- 모병
- Toulouse University Hospital
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Haute-Vienne
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Limoges, Haute-Vienne, 프랑스, 87000
- 모병
- Limoges University Hospital
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, 프랑스, 35000
- 모병
- Rennes University Hospital
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Indre-et-Loire
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Tours, Indre-et-Loire, 프랑스, 37000
- 모병
- Tours University Hospital
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Loire-Atlantique
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Nantes, Loire-Atlantique, 프랑스, 44000
- 모병
- Nantes University Hospital
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수석 연구원:
- Romain BOURCIER, MD
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Maine et Loire
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Angers, Maine et Loire, 프랑스, 49000
- 모병
- Angers University Hospital
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Marne
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Reims, Marne, 프랑스, 51100
- 빼는
- Reims University Hospital
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Meurthe-et-Moselle
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Nancy, Meurthe-et-Moselle, 프랑스, 54000
- 모병
- Nancy University Hospital
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Paris
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Paris, Paris, 프랑스, 75000
- 모병
- AP-HP La Pitié-Salpêtrière Hospital
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Paris, Paris, 프랑스, 75000
- 모병
- AP-HP Le Kremlin Bicêtre Hospital
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Paris, Paris, 프랑스, 75000
- 모병
- Rostchild Foundation Hospital
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Seine-Maritime
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Rouen, Seine-Maritime, 프랑스, 76000
- 모병
- Rouen University Hospital
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Somme
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Amiens, Somme, 프랑스, 80000
- 모병
- Amiens University Hospital
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Île-de-France Region
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Paris, Île-de-France Region, 프랑스, 75674
- 모병
- Ste Anne's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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.
기간: 5 years
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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
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Predictive value of UIA wall enhancement for UIA growth
기간: at 1 year
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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
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Predictive value of UIA wall enhancement for UIA growth
기간: at 3 years
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of life related to the growth of UIA.
기간: 5 years
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Evaluation of the quality of life (QOL) of untreated patients with UIA during the follow-up. |
5 years
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AWE variation patterns related to the growth of UIA.
기간: 5 years
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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
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Clinical, genetics or biological factors related to the growth of UIA.
기간: 5 years
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Clinical, genetic (blood serum level of circulating ANGPTL6) and biological (plasma factors as circulating ANGPTL6 levels, metalloproteinase…) features recorded. |
5 years
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Incidence of growth of UIA.
기간: 5 years
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Incidence of growth, stratified by clinical, genetics or biological features. |
5 years
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Incidence of IA rupture
기간: 5 years
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Incidence of IA rupture, stratified by clinical, genetics or biological features. |
5 years
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quality of life patients related to the growth of UIA.
기간: 5 years
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Completion of standardized EQ5D questionnaire to measure quality of life patients |
5 years
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Construction of an automatized tool of AWE pattern
기간: 5 years
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Romain BOURCIER, MD, Nantes University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RC20_0012
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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