Looking For Genetic and Environmental Risk Factors and Therapeutic Aspects in Cervical Artery Dissections (CADISP)

October 20, 2009 updated by: Cervical Artery Dissections and Ischemic Stroke Patients - Consortium
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

Study Overview

Status

Unknown

Conditions

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

Enrollment (Actual)

4169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5000
        • Sanatorio Allende
  • Belgium
      • Brussels, Belgium, 1070
        • Department of Neurology, University Hospital of Brussels (ULB)
      • Leuven, Belgium, 3000
        • Department of Neurology, University Hospital of Leuven
  • Finland
      • Helsinki, Finland, 00290
        • Department of Neurology, Helsinki University Central Hospital
  • France
      • Amiens, France, 80000
        • Department of Neurology, University Hospital of Amiens
      • Besançon, France, 25000
        • Department of Neurology, University Hospital of Besançon
      • Dijon, France, 21000
        • Department of Neurology, University Hospital of Dijon
      • Lille, France, 59000
        • Department of Neurology, University Hospital of Lille
      • Lille, France, 59000
        • Inserm U744 Institut Pasteur de Lille
      • Paris, France, 75013
        • Department of Neurology, University Hospital Pitié-Salpêtrière
      • Paris, France, 75015
        • Department of Neurology, University Hospital Sainte-Anne
  • Germany
      • Heidelberg, Germany, 62120
        • Rehabilitation Center, Schmieder-Klinik
      • Heidelberg, Germany, 69120
        • Department of Neurology, University Hospital of Heidelberg
      • Ludwigshafen, Germany, 67063
        • Department of Neurology, Hospital of Ludwigshafen
      • Munich, Germany, 81377
        • Department of Neurology, University Hospital of Munich
  • Italy
      • Brescia, Italy, 25100
        • Department of Neurology, University Hospital of Brescia
      • Milano, Italy, 20100
        • Department of Neurology, Ospedale Maggiore Policlinico di Milano
      • Milano, Italy, 20132
        • Ospedale Milano San Raffaele
      • Monza, Italy, 20052
        • Department of Neurology, University Hospital Milano-Bicocca
      • Perugia, Italy, 06081
        • Department of Neurology, University Hospital of Perugia
      • Rome, Italy, 00100
        • Rehabilitation Center, IRCCS Santa Lucia, Roma
  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Neurology, University Hospital of Basel
  • Turkey
      • Istanbul, Turkey
        • Department of Neurology, Cerrahpasa Medical Faculty, Istanbul University
  • United Kingdom
      • London, United Kingdom, SW170RE
        • Department of Neuroscience, St George's University Hospital of London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

groups 1 and 2: hospital-based, neurology departments group 3: community samples

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
association of genetic polymorphisms with cervical artery dissections
Time Frame: 2009
2009

Secondary Outcome Measures

Outcome Measure
Time Frame
association of environmental risk factors with cervical artery dissections
Time Frame: 2009
2009
gene-environment interactions
Time Frame: 2009
2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cervical Artery Dissections and Ischemic Stroke Patients - Consortium

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ANTICIPATED)

September 1, 2009

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (ESTIMATE)

April 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2009

Last Update Submitted That Met QC Criteria

October 20, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CADISP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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