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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
Sponsor:
Information provided by:
Cervical Artery Dissections and Ischemic Stroke Patients - Consortium

Tracking Information
First Submitted Date April 8, 2008
First Posted Date April 14, 2008
Last Update Posted Date October 21, 2009
Study Start Date July 2005
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2008)
association of genetic polymorphisms with cervical artery dissections [ Time Frame: 2009 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00657969 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 11, 2008)
  • association of environmental risk factors with cervical artery dissections [ Time Frame: 2009 ]
  • gene-environment interactions [ Time Frame: 2009 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Looking For Genetic and Environmental Risk Factors and Therapeutic Aspects in Cervical Artery Dissections
Official Title Looking For Genetic and Environmental Risk Factors and Therapeutic Aspects in Cervical Artery Dissections
Brief Summary The main purpose of this study is to look for genetic and environmental risk factors of cervical artery dissections, a major cause of ischemic stroke in young adults, in a large multicenter case-control trial
Detailed Description

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
Study Design Observational Model: Case Control
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA, plasma, serum
Sampling Method Non-Probability Sample
Study Population groups 1 and 2: hospital-based, neurology departments group 3: community samples
Condition
  • Cervical Artery Dissection
  • Stroke
  • Brain Infarction
Intervention Not Provided
Study Groups/Cohorts
  • 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
  • 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
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: May 30, 2009)
4169
Original Estimated Enrollment
 (submitted: April 11, 2008)
4150
Estimated Study Completion Date September 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

GROUP1:

Inclusion Criteria:

  • Typical radiological aspect of dissection* in a cervical artery (carotid and/or vertebral);* Mural hematoma, pseudoaneurysm, long tapering stenosis, intimal flap, double lumen, or occlusion > 2 cm above the carotid bifurcation revealing a pseudo aneurysm or a long tapering stenosis after recanalisation
  • Written informed consent

Exclusion Criteria:

  • Purely intracranial dissection
  • Dissection occurring after an endovascular procedure
  • Known mendelian genetic disorder that can explain the dissection (e.g. vascular Ehlers-Danlos syndrome)

GROUP2:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

Inclusion criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Belgium,   Finland,   France,   Germany,   Italy,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00657969
Other Study ID Numbers CADISP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. S Debette, Dr. C Grond-Ginsbach, Pr. D Leys, University Hospitals of Heidelberg and Lille
Study Sponsor Cervical Artery Dissections and Ischemic Stroke Patients - Consortium
Collaborators Not Provided
Investigators
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
PRS Account Cervical Artery Dissections and Ischemic Stroke Patients - Consortium
Verification Date October 2009