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

NCT00657969 | Unknown

• 1 other identifier: CADISP
• Study Type: observational
• Target: 4,169
• Locations: 9 countries
• Sites: 24

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

Conditions

Cervical Artery Dissection; Stroke; Brain Infarction

Keywords

Polymorphism, genetic; Risk factors; Carotid Artery, Internal, Dissection; Vertebral Artery Dissection; Genetic predisposition; Outcome; Therapy

Outcome Measures

Primary Outcomes (1)

• association of genetic polymorphisms with cervical artery dissections

  2009

Secondary Outcomes (2)

• association of environmental risk factors with cervical artery dissections

  2009

• gene-environment interactions

  2009

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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:

Sponsors & Collaborators

• Cervical Artery Dissections and Ischemic Stroke Patients - Consortium: lead

Study Sites (24)

Sanatorio Allende

Córdoba, 5000, Argentina

Location

Department of Neurology, University Hospital of Brussels (ULB)

Brussels, 1070, Belgium

Location

Department of Neurology, University Hospital of Leuven

Leuven, 3000, Belgium

Location

Department of Neurology, Helsinki University Central Hospital

Helsinki, 00290, Finland

Location

Department of Neurology, University Hospital of Amiens

Amiens, 80000, France

Location

Department of Neurology, University Hospital of Besançon

Besançon, 25000, France

Location

Department of Neurology, University Hospital of Dijon

Dijon, 21000, France

Location

Department of Neurology, University Hospital of Lille

Lille, 59000, France

Location

Inserm U744 Institut Pasteur de Lille

Lille, 59000, France

Location

Department of Neurology, University Hospital Pitié-Salpêtrière

Paris, 75013, France

Location

Department of Neurology, University Hospital Sainte-Anne

Paris, 75015, France

Location

Rehabilitation Center, Schmieder-Klinik

Heidelberg, 62120, Germany

Location

Department of Neurology, University Hospital of Heidelberg

Heidelberg, 69120, Germany

Location

Department of Neurology, Hospital of Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Department of Neurology, University Hospital of Munich

Munich, 81377, Germany

Location

Department of Neurology, University Hospital of Brescia

Brescia, 25100, Italy

Location

Department of Neurology, Ospedale Maggiore Policlinico di Milano

Milan, 20100, Italy

Location

Ospedale Milano San Raffaele

Milan, 20132, Italy

Location

Department of Neurology, University Hospital Milano-Bicocca

Monza, 20052, Italy

Location

Department of Neurology, University Hospital of Perugia

Perugia, 06081, Italy

Location

Rehabilitation Center, IRCCS Santa Lucia, Roma

Rome, 00100, Italy

Location

Department of Neurology, University Hospital of Basel

Basel, 4031, Switzerland

Location

Department of Neurology, Cerrahpasa Medical Faculty, Istanbul University

Istanbul, Turkey (Türkiye)

Location

Department of Neuroscience, St George's University Hospital of London

London, SW170RE, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 17656656 BACKGROUND

• 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.

  PMID: 19659826 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA, plasma, serum

MeSH Terms

Conditions

Stroke; Brain Infarction; Carotid Artery, Internal, Dissection; Vertebral Artery Dissection; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Carotid Artery Injuries; Carotid Artery Diseases; Cerebrovascular Trauma; Trauma, Nervous System; Dissection, Blood Vessel; Aneurysm; Wounds and Injuries; Disease Susceptibility; Disease Attributes

Study Officials

• Stéphanie Debette, MD, PhD

  Department of Neurology (EA2691), University Hospital of Lille; Inserm, U744, Pasteur Institute, Lille, France

  STUDY DIRECTOR

• Caspar Grond-Ginsbach, PhD

  Department of Neurology, University Hospital of Heidelberg, Germany

  STUDY CHAIR

• Didier Leys, MD PhD

  Department of Neurology (EA2691), University Hospital of Lille, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: July 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 21, 2009

Record last verified: 2009-10

Locations

GB (1); FI (1); FR (7); TU (1); IT (6); CH (1); BE (2); AR (1); DE (4)