未破裂脳動脈瘤：進化の予測 (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.
調査の概要
詳細な説明
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).
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Romain BOURCIER, MD
- 電話番号：33240165608
- メール：romain.bourcier@chu-nantes.fr
研究場所
-
-
-
Utrecht、オランダ、3500
- 完了
- UMC Utrecht
-
-
-
-
-
Bern、スイス、3000
- まだ募集していません
- InselHospital Bern
-
-
-
-
-
Besançon、フランス
- 募集
- CHU de Besançon
-
主任研究者：
- Alessandra BIONDI
-
コンタクト：
- Alessandra BIONDI
- 電話番号：+33 3 81 66 81 66
- メール：biondi.alessandra@gmail.com
-
Caen、フランス
- 募集
- CHU de Caen
-
コンタクト：
- Charlotte BARBIER
- 電話番号：+33 2 31 06 31 06
- メール：barbier-ch@chu-caen.fr
-
主任研究者：
- Charlotte BARBIER
-
Clermont-Ferrand、フランス
- 募集
- CHU de Clermont Ferrand
-
コンタクト：
- Emmanuel CHABERT
- 電話番号：+33 4 73 751 747
- メール：echabert@chu-clermontferrand.fr
-
主任研究者：
- Emmanuel CHABERT
-
Colmar、フランス
- まだ募集していません
- Hôpitaux Civils de Colmar
-
コンタクト：
- Pablo Ariel LEBEDINSKY, MD
- 電話番号：+33 3.89.12.44.39
- メール：pablo.lebedinsky@ch-colmar.fr
-
主任研究者：
- Pablo Ariel LEBEDINSKY
-
Dijon、フランス
- 募集
- CHU Dijon
-
コンタクト：
- Pierre THOUANT
- 電話番号：+33 3 80 29 30 31
- メール：pierrethouant@gmail.com
-
主任研究者：
- Pierre THOUANT
-
Poitiers、フランス
- 募集
- CHU de Poitiers
-
主任研究者：
- Samy BOUCEBCI
-
コンタクト：
- Samy BOUCEBCI
- 電話番号：+33 5 49 44 44 44
- メール：Samy.BOUCEBCI@chu-poitiers.fr
-
Saint-Etienne、フランス
- 募集
- CHU de saint Etienne
-
主任研究者：
- Marina SACHET
-
コンタクト：
- Marina SACHET
- 電話番号：+33 4 77 82 80 00
- メール：Marina.Sachet@chu-st-etienne.fr
-
Strasbourg、フランス
- 募集
- CHU de Strasbourg
-
主任研究者：
- Raoul POP
-
コンタクト：
- Raoul POP
- 電話番号：+33 3 88 11 67 68
- メール：raoul.pop@chru-strasbourg.fr
-
Suresnes、フランス
- 募集
- Hôpital Foch
-
主任研究者：
- Arturo CONSOLI
-
コンタクト：
- Arturo CONSOLI
- 電話番号：+33 1 46 25 20 00
- メール：a.consoli@hopital-foch.com
-
Toulon、フランス
- 募集
- St Anne HIA
-
コンタクト：
- Quentin Holay
- メール：qholay@gmail.com
-
-
Bouches-du-Rhône
-
Marseille、Bouches-du-Rhône、フランス、13000
- 募集
- Clairval's Hospital
-
-
Finistère
-
Brest、Finistère、フランス、29200
- 募集
- Brest University Hospital
-
-
Gironde
-
Bordeaux、Gironde、フランス、33000
- 募集
- Bordeaux University Hospital
-
-
Haute-Garonne
-
Toulouse、Haute-Garonne、フランス、31000
- 募集
- Toulouse University Hospital
-
-
Haute-Vienne
-
Limoges、Haute-Vienne、フランス、87000
- 募集
- Limoges University Hospital
-
-
Ille-et-Vilaine
-
Rennes、Ille-et-Vilaine、フランス、35000
- 募集
- Rennes University Hospital
-
-
Indre-et-Loire
-
Tours、Indre-et-Loire、フランス、37000
- 募集
- Tours University Hospital
-
-
Loire-Atlantique
-
Nantes、Loire-Atlantique、フランス、44000
- 募集
- Nantes University Hospital
-
主任研究者：
- Romain BOURCIER, MD
-
-
Maine et Loire
-
Angers、Maine et Loire、フランス、49000
- 募集
- Angers University Hospital
-
-
Marne
-
Reims、Marne、フランス、51100
- 引きこもった
- Reims University Hospital
-
-
Meurthe-et-Moselle
-
Nancy、Meurthe-et-Moselle、フランス、54000
- 募集
- Nancy University Hospital
-
-
Paris
-
Paris、Paris、フランス、75000
- 募集
- AP-HP La Pitié-Salpêtrière Hospital
-
Paris、Paris、フランス、75000
- 募集
- AP-HP Le Kremlin Bicêtre Hospital
-
Paris、Paris、フランス、75000
- 募集
- Rostchild Foundation Hospital
-
-
Seine-Maritime
-
Rouen、Seine-Maritime、フランス、76000
- 募集
- Rouen University Hospital
-
-
Somme
-
Amiens、Somme、フランス、80000
- 募集
- Amiens University Hospital
-
-
Île-de-France Region
-
Paris、Île-de-France Region、フランス、75674
- 募集
- Ste Anne's Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of life related to the growth of UIA.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：5 years
|
Incidence of growth, stratified by clinical, genetics or biological features. |
5 years
|
|
Incidence of IA rupture
時間枠：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.
時間枠：5 years
|
Completion of standardized EQ5D questionnaire to measure quality of life patients |
5 years
|
|
Construction of an automatized tool of AWE pattern
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Romain BOURCIER, MD、Nantes University Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。