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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Cervical Artery Dissections and Ischemic Stroke Patients - Consortium.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Cervical Artery Dissections and Ischemic Stroke Patients - Consortium
ClinicalTrials.gov Identifier:
NCT00657969
First received: April 8, 2008
Last updated: October 20, 2009
Last verified: October 2009
  Purpose

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


Condition
Cervical Artery Dissection
Stroke
Brain Infarction

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Looking For Genetic and Environmental Risk Factors and Therapeutic Aspects in Cervical Artery Dissections

Resource links provided by NLM:


Further study details as provided by Cervical Artery Dissections and Ischemic Stroke Patients - Consortium:

Primary Outcome Measures:
  • association of genetic polymorphisms with cervical artery dissections [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • association of environmental risk factors with cervical artery dissections [ Time Frame: 2009 ] [ Designated as safety issue: No ]
  • gene-environment interactions [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA, plasma, serum


Enrollment: 4169
Study Start Date: July 2005
Estimated Study Completion Date: September 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657969

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

Publications:
Responsible Party: Dr. S Debette, Dr. C Grond-Ginsbach, Pr. D Leys, University Hospitals of Heidelberg and Lille
ClinicalTrials.gov Identifier: NCT00657969     History of Changes
Other Study ID Numbers: CADISP
Study First Received: April 8, 2008
Last Updated: October 20, 2009
Health Authority: France: Direction Générale de la Santé
Finland: Ethics Committee
Germany: Ethics Commission
Italy: Ethics Committee
Belgium: Institutional Review Board
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee
Turkey: Ethics Committee

Keywords provided by Cervical Artery Dissections and Ischemic Stroke Patients - Consortium:
Polymorphism, genetic
Risk factors
Carotid Artery, Internal, Dissection
Vertebral Artery Dissection
Genetic predisposition
Outcome
Therapy

Additional relevant MeSH terms:
Aneurysm, Dissecting
Infarction
Stroke
Brain Infarction
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Ischemia

ClinicalTrials.gov processed this record on August 27, 2014