Looking For Genetic and Environmental Risk Factors and Therapeutic Aspects in Cervical Artery Dissections
NCT ID: NCT00657969
Last Updated: 2009-10-21
Study Results
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Basic Information
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UNKNOWN
4169 participants
OBSERVATIONAL
2005-07-31
2009-09-30
Brief Summary
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Detailed Description
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Aim: Our main aim is to look for genetic and environmental risk factors and gene-environment interactions potentially underlying CAD. In addition, therapeutic aspects are addressed in the setting of a multicenter registry.
Methods: We organized a multinational European network, CADISP (Cervical Artery Dissection and Ischemic Stroke Patients) which targets at increasing our knowledge on the pathophysiological mechanisms of this disease in a large, representative patient population. Within this network, we are aiming to perform a de novo genetic association analysis using both a genome-wide and a candidate gene approach. For this purpose, 1130 patients with CAD, 1130 patients with non-CAD ischemic stroke, and 1890 healthy controls are being recruited, and detailed clinical, laboratory, diagnostic, therapeutic and outcome data are being collected from all participating patients. We are expecting to reach the above numbers of subjects by the end of 2008. Analyses of the CADISP database might clarify a number of debated issues, including risk factors, stroke preventive treatment, and outcome predictors of CAD.
We present the strategy of a collaborative project searching for genetic risk factors of cervical artery dissections. We hope that the CADISP network will provide detailed and novel data on risk factors and treatment aspects of CAD.
Conditions
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Study Design
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CASE_CONTROL
Study Groups
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1
CAD-group (Cervical Artery Dissection - group): consecutive patients with cervical artery dissection, with or without associated cerebral ischemia, hospitalized in one of the participating neurological centers; standardized inclusion and exclusion criteria apply
No interventions assigned to this group
2
IS-group (Ischemic Stroke - Group): patients selected among consecutive patients hospitalized for an ischemic stroke without CAD, in the same centers as patients from group1, frequency-matched on age and gender with group1; standardized inclusion and exclusion criteria apply
No interventions assigned to this group
3
HC-group (Healthy Control - Group): DNA of healthy individuals from existing DNA-databases will be used as controls for the Belgian, French, German and Swiss centers; the other centers are recruiting their own age- and sex-matched healthy controls; individuals from the 3 groups (CAD, IS and HC) are strictly matched on geographical origin in order to avoid stratification bias
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* Recent ischemic stroke
* No signs of CAD on extracranial duplex sonography and angiography (digital subtraction or magnetic resonance or CT), performed \< 7 days after the stroke
* Written informed consent
* Individuals from the general population without history of stroke, dissections in any artery, transient ischemic attack, coronary artery disease, peripheral artery disease
* Written informed consent
Exclusion Criteria
* Dissection occurring after an endovascular procedure
* Known mendelian genetic disorder that can explain the dissection (e.g. vascular Ehlers-Danlos syndrome)
GROUP2:
* Possible cerebral ischemia but normal cerebral imaging
* CAD cannot be ruled out (e.g.persistent arterial occlusion without mural hematoma)
* Endovascular or surgical procedure on the coronary, cervical or cerebral arteries during the 48 hours preceding the cerebral infarction
* Cardiopathies with a very high embolic risk (Mechanical prosthetic valves, mitral stenosis with atrial fibrillation, intracardiac tumor, infectious endocarditis, myocardial infarction\<4 months)
* Arterial vasospasm following a subarachnoid haemorrhage
* Auto-immune disease possibly responsible for the cerebral infarction
* Known monogenic disease responsible for the cerebral infarction
GROUP3:
18 Years
ALL
No
Sponsors
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Cervical Artery Dissections and Ischemic Stroke Patients - Consortium
NETWORK
Responsible Party
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University Hospitals of Heidelberg and Lille
Principal Investigators
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Stéphanie Debette, MD, PhD
Role: STUDY_DIRECTOR
Department of Neurology (EA2691), University Hospital of Lille; Inserm, U744, Pasteur Institute, Lille, France
Caspar Grond-Ginsbach, PhD
Role: STUDY_CHAIR
Department of Neurology, University Hospital of Heidelberg, Germany
Didier Leys, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology (EA2691), University Hospital of Lille, France
Locations
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Sanatorio Allende
Córdoba, , Argentina
Department of Neurology, University Hospital of Brussels (ULB)
Brussels, , Belgium
Department of Neurology, University Hospital of Leuven
Leuven, , Belgium
Department of Neurology, Helsinki University Central Hospital
Helsinki, , Finland
Department of Neurology, University Hospital of Amiens
Amiens, , France
Department of Neurology, University Hospital of Besançon
Besançon, , France
Department of Neurology, University Hospital of Dijon
Dijon, , France
Department of Neurology, University Hospital of Lille
Lille, , France
Inserm U744 Institut Pasteur de Lille
Lille, , France
Department of Neurology, University Hospital Pitié-Salpêtrière
Paris, , France
Department of Neurology, University Hospital Sainte-Anne
Paris, , France
Rehabilitation Center, Schmieder-Klinik
Heidelberg, , Germany
Department of Neurology, University Hospital of Heidelberg
Heidelberg, , Germany
Department of Neurology, Hospital of Ludwigshafen
Ludwigshafen, , Germany
Department of Neurology, University Hospital of Munich
Munich, , Germany
Department of Neurology, University Hospital of Brescia
Brescia, , Italy
Department of Neurology, Ospedale Maggiore Policlinico di Milano
Milan, , Italy
Ospedale Milano San Raffaele
Milan, , Italy
Department of Neurology, University Hospital Milano-Bicocca
Monza, , Italy
Department of Neurology, University Hospital of Perugia
Perugia, , Italy
Rehabilitation Center, IRCCS Santa Lucia, Roma
Rome, , Italy
Department of Neurology, University Hospital of Basel
Basel, , Switzerland
Department of Neurology, Cerrahpasa Medical Faculty, Istanbul University
Istanbul, , Turkey (Türkiye)
Department of Neuroscience, St George's University Hospital of London
London, , United Kingdom
Countries
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References
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Engelter ST, Brandt T, Debette S, Caso V, Lichy C, Pezzini A, Abboud S, Bersano A, Dittrich R, Grond-Ginsbach C, Hausser I, Kloss M, Grau AJ, Tatlisumak T, Leys D, Lyrer PA; Cervical Artery Dissection in Ischemic Stroke Patients (CADISP) Study Group. Antiplatelets versus anticoagulation in cervical artery dissection. Stroke. 2007 Sep;38(9):2605-11. doi: 10.1161/STROKEAHA.107.489666. Epub 2007 Jul 26.
Debette S, Metso TM, Pezzini A, Engelter ST, Leys D, Lyrer P, Metso AJ, Brandt T, Kloss M, Lichy C, Hausser I, Touze E, Markus HS, Abboud S, Caso V, Bersano A, Grau A, Altintas A, Amouyel P, Tatlisumak T, Dallongeville J, Grond-Ginsbach C; CADISP-group. CADISP-genetics: an International project searching for genetic risk factors of cervical artery dissections. Int J Stroke. 2009 Jun;4(3):224-30. doi: 10.1111/j.1747-4949.2009.00281.x.
Other Identifiers
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CADISP
Identifier Type: -
Identifier Source: org_study_id
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