Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications (GENERAC)
2017年2月27日 更新者：Assistance Publique - Hôpitaux de Paris
Pathophysiology of Aortic Valve Stenosis remains poorly known.
The aim of the present study is to identify genetic factors involved in this disease using a case control trial design.
研究概览
地位
未知
条件
详细说明
Aortic valve stenosis (AS) is the most common valvular disease and the second most common indication for cardiac surgery in Western countries.
AS has long been considered as a passive and degenerative process.
Recent data challenged this concept, showing that AS is an active and highly regulated process with some similarities to atherosclerosis.
However, pathophysiology of AS remains poorly understood and preliminary data suggest that genetic factors may be involved.
The aim of the present study is to identify genetic factors involved in this disease using a case control trial design (1000 patients with AS and 1500 controls with no evidence of valve disease).
For all patients and controls, blood samples including DNA and echocardiography will be performed.
研究类型
观察性的
注册 (预期的)
2200
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Paris、法国、75018
- 招聘中
- Assistance Publique - Hôpitaux de Paris, Bichat Hospital
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接触：
- David MESSIKA-ZEITOUN, MD
- 电话号码：00 33 01 40 25 66 01
- 邮箱：david.messika-zeitoun@bch.aphp.fr
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首席研究员：
- David Messika-Zeitoun
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
case control study Case = patients with aortic valve stenosis Controls = participants free of aortic valve stenosis
描述
Patients:
Inclusion criteria :
- Age >=18 years
- Pure isolated degenerative aortic valve stenosis
Exclusion criteria :
- Rheumatic, congenital or post-radiation aortic stenosis
- Severe renal insufficiency (clearance < 30 ml/min)
- Aortic insufficiency > or = grade 2/4
- Other valve disease > or = grade 2/4
Controls
Inclusion criteria :
- Age >=18 years
Exclusion criteria :
- Known first degree relative with aortic valve stenosis
- Severe renal insufficiency (clearance < 30 ml/min)
- Any valve disease > or = grade 2/4
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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aortic stenosis
various age and disease severity
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Controls
Controls free of valvular disease
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Identification of genetic polymorphisms of fetuin-A, matrix-GLA protein, vitamin D receptor
大体时间：end of the study
|
end of the study
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Identification of other genetic polymorphisms
大体时间：End of the Study
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End of the Study
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：David Messika-Zeitoun, MD、Assistance Publique - Hôpitaux de Paris
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Pawade T, Clavel MA, Tribouilloy C, Dreyfus J, Mathieu T, Tastet L, Renard C, Gun M, Jenkins WSA, Macron L, Sechrist JW, Lacomis JM, Nguyen V, Galian Gay L, Cuellar Calabria H, Ntalas I, Cartlidge TRG, Prendergast B, Rajani R, Evangelista A, Cavalcante JL, Newby DE, Pibarot P, Messika Zeitoun D, Dweck MR. Computed Tomography Aortic Valve Calcium Scoring in Patients With Aortic Stenosis. Circ Cardiovasc Imaging. 2018 Mar;11(3):e007146. doi: 10.1161/CIRCIMAGING.117.007146.
- Perrot N, Theriault S, Dina C, Chen HY, Boekholdt SM, Rigade S, Despres AA, Poulin A, Capoulade R, Le Tourneau T, Messika-Zeitoun D, Trottier M, Tessier M, Guimond J, Nadeau M, Engert JC, Khaw KT, Wareham NJ, Dweck MR, Mathieu P, Pibarot P, Schott JJ, Thanassoulis G, Clavel MA, Bosse Y, Arsenault BJ. Genetic Variation in LPA, Calcific Aortic Valve Stenosis in Patients Undergoing Cardiac Surgery, and Familial Risk of Aortic Valve Microcalcification. JAMA Cardiol. 2019 Jul 1;4(7):620-627. doi: 10.1001/jamacardio.2019.1581. Erratum In: JAMA Cardiol. 2019 Jul 1;4(7):714.
- Arangalage D, Nguyen V, Robert T, Melissopoulou M, Mathieu T, Estellat C, Codogno I, Huart V, Duval X, Cimadevilla C, Vahanian A, Dehoux M, Messika-Zeitoun D. Determinants and prognostic value of Galectin-3 in patients with aortic valve stenosis. Heart. 2016 Jun 1;102(11):862-8. doi: 10.1136/heartjnl-2015-308873. Epub 2016 Feb 19.
- Chin CW, Messika-Zeitoun D, Shah AS, Lefevre G, Bailleul S, Yeung EN, Koo M, Mirsadraee S, Mathieu T, Semple SI, Mills NL, Vahanian A, Newby DE, Dweck MR. A clinical risk score of myocardial fibrosis predicts adverse outcomes in aortic stenosis. Eur Heart J. 2016 Feb 21;37(8):713-23. doi: 10.1093/eurheartj/ehv525. Epub 2015 Oct 21.
- Nguyen V, Cimadevilla C, Estellat C, Codogno I, Huart V, Benessiano J, Duval X, Pibarot P, Clavel MA, Enriquez-Sarano M, Vahanian A, Messika-Zeitoun D. Haemodynamic and anatomic progression of aortic stenosis. Heart. 2015 Jun;101(12):943-7. doi: 10.1136/heartjnl-2014-307154. Epub 2015 Feb 5.
- Cimadevilla C, Cueff C, Hekimian G, Dehoux M, Lepage L, Iung B, Duval X, Huart V, Tubach F, Vahanian A, Messika-Zeitoun D. Prognostic value of B-type natriuretic peptide in elderly patients with aortic valve stenosis: the COFRASA-GENERAC study. Heart. 2013 Apr;99(7):461-7. doi: 10.1136/heartjnl-2012-303284. Epub 2013 Jan 24.
- Kubota N, David Messika-Zeitoun D. P650Influence of fetunin-a level on progression of calcific aortic valve stenosis The COFRASA - GENERAC Study. Eur Heart J Cardiovasc Imaging. 2016 Dec 1;17(suppl_2):ii130-ii136. doi: 10.1093/ehjci/jew250.001.
- Guauque-Olarte S, Messika-Zeitoun D, Droit A, Lamontagne M, Tremblay-Marchand J, Lavoie-Charland E, Gaudreault N, Arsenault BJ, Dube MP, Tardif JC, Body SC, Seidman JG, Boileau C, Mathieu P, Pibarot P, Bosse Y. Calcium Signaling Pathway Genes RUNX2 and CACNA1C Are Associated With Calcific Aortic Valve Disease. Circ Cardiovasc Genet. 2015 Dec;8(6):812-22. doi: 10.1161/CIRCGENETICS.115.001145. Epub 2015 Nov 9.
- Dreyfus J, Durand-Viel G, Raffoul R, Alkhoder S, Hvass U, Radu C, Al-Attar N, Ghodbhane W, Attias D, Nataf P, Vahanian A, Messika-Zeitoun D. Comparison of 2-Dimensional, 3-Dimensional, and Surgical Measurements of the Tricuspid Annulus Size: Clinical Implications. Circ Cardiovasc Imaging. 2015 Jul;8(7):e003241. doi: 10.1161/CIRCIMAGING.114.003241.
- Kochtebane N, Passefort S, Choqueux C, Ainoun F, Achour L, Michel JB, Back M, Jacob MP. Release of leukotriene B4, transforming growth factor-beta1 and microparticles in relation to aortic valve calcification. J Heart Valve Dis. 2013 Nov;22(6):782-8.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年3月1日
初级完成 (预期的)
2017年12月1日
研究完成 (预期的)
2017年12月1日
研究注册日期
首次提交
2008年3月26日
首先提交符合 QC 标准的
2008年3月26日
首次发布 (估计)
2008年3月31日
研究记录更新
最后更新发布 (实际的)
2017年3月1日
上次提交的符合 QC 标准的更新
2017年2月27日
最后验证
2016年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.