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

Stroke Clinical Trial

— CADISP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00657969
• Other study ID #: CADISP
• Status: Active, not recruiting
• Phase: N/A
• First received: April 8, 2008
• Last updated: October 20, 2009
• Start date: July 2005
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: Cervical Artery Dissections and Ischemic Stroke Patients - Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFinland: Ethics CommitteeGermany: Ethics CommissionItaly: Ethics CommitteeBelgium: Institutional Review BoardSwitzerland: EthikkommissionUnited Kingdom: Research Ethics CommitteeTurkey: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4169
• Est. completion date: September 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Brain Infarction
• Cervical Artery Dissection
• Stroke

Locations

Country	Name	City	State
Argentina	Sanatorio Allende	Cordoba
Belgium	Department of Neurology, University Hospital of Brussels (ULB)	Brussels
Belgium	Department of Neurology, University Hospital of Leuven	Leuven
Finland	Department of Neurology, Helsinki University Central Hospital	Helsinki
France	Department of Neurology, University Hospital of Amiens	Amiens
France	Department of Neurology, University Hospital of Besançon	Besançon
France	Department of Neurology, University Hospital of Dijon	Dijon
France	Department of Neurology, University Hospital of Lille	Lille
France	Inserm U744 Institut Pasteur de Lille	Lille
France	Department of Neurology, University Hospital Pitié-Salpêtrière	Paris
France	Department of Neurology, University Hospital Sainte-Anne	Paris
Germany	Department of Neurology, University Hospital of Heidelberg	Heidelberg
Germany	Rehabilitation Center, Schmieder-Klinik	Heidelberg
Germany	Department of Neurology, Hospital of Ludwigshafen	Ludwigshafen
Germany	Department of Neurology, University Hospital of Munich	Munich
Italy	Department of Neurology, University Hospital of Brescia	Brescia
Italy	Department of Neurology, Ospedale Maggiore Policlinico di Milano	Milano
Italy	Ospedale Milano San Raffaele	Milano
Italy	Department of Neurology, University Hospital Milano-Bicocca	Monza
Italy	Department of Neurology, University Hospital of Perugia	Perugia
Italy	Rehabilitation Center, IRCCS Santa Lucia, Roma	Rome
Switzerland	Department of Neurology, University Hospital of Basel	Basel
Turkey	Department of Neurology, Cerrahpasa Medical Faculty, Istanbul University	Istanbul
United Kingdom	Department of Neuroscience, St George's University Hospital of London	London

Sponsors (1)

Lead Sponsor	Collaborator
Cervical Artery Dissections and Ischemic Stroke Patients - Consortium

Countries where clinical trial is conducted

Argentina,  Belgium,  Finland,  France,  Germany,  Italy,  Switzerland,  Turkey,  United Kingdom, 

References & Publications (2)

Debette S, Metso TM, Pezzini A, Engelter ST, Leys D, Lyrer P, Metso AJ, Brandt T, Kloss M, Lichy C, Hausser I, Touzé 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. — View Citation

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. Epub 2007 Jul 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	association of genetic polymorphisms with cervical artery dissections		2009	No
Secondary	association of environmental risk factors with cervical artery dissections		2009	No
Secondary	gene-environment interactions		2009	No