Looking For Genetic and Environmental Risk Factors and Therapeutic Aspects in Cervical Artery Dissections (CADISP)
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|ClinicalTrials.gov Identifier: NCT00657969|
Recruitment Status : Unknown
Verified October 2009 by Cervical Artery Dissections and Ischemic Stroke Patients - Consortium.
Recruitment status was: Active, not recruiting
First Posted : April 14, 2008
Last Update Posted : October 21, 2009
|Condition or disease|
|Cervical Artery Dissection Stroke Brain Infarction|
Background: Cervical artery dissections (CAD) are a major cause of ischemic stroke, longstanding disability, and occasionally death in young adults. Several lines of evidence suggest genetic predisposition for CAD. Previous genetic studies were, however, inconclusive mainly due to insufficient numbers of patients. Our hypothesis is that CAD is a multifactorial disease caused by yet largely unidentified genetic variants and environmental factors, which may interact.
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.
|Study Type :||Observational|
|Actual Enrollment :||4169 participants|
|Official Title:||Looking For Genetic and Environmental Risk Factors and Therapeutic Aspects in Cervical Artery Dissections|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||January 2009|
|Estimated Study Completion Date :||September 2009|
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
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
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
- association of genetic polymorphisms with cervical artery dissections [ Time Frame: 2009 ]
- association of environmental risk factors with cervical artery dissections [ Time Frame: 2009 ]
- gene-environment interactions [ Time Frame: 2009 ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657969
|Study Director:||Stéphanie Debette, MD, PhD||Department of Neurology (EA2691), University Hospital of Lille; Inserm, U744, Pasteur Institute, Lille, France|
|Study Chair:||Caspar Grond-Ginsbach, PhD||Department of Neurology, University Hospital of Heidelberg, Germany|
|Principal Investigator:||Didier Leys, MD PhD||Department of Neurology (EA2691), University Hospital of Lille, France|