Looking For Genetic and Environmental Risk Factors and Therapeutic Aspects in Cervical Artery Dissections (CADISP)
Recruitment status was Active, not recruiting
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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 |
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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 |
- association of genetic polymorphisms with cervical artery dissections [ Time Frame: 2009 ] [ Designated as safety issue: No ]
- 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 |
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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
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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
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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
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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 |
groups 1 and 2: hospital-based, neurology departments group 3: community samples
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| 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 | |
| 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
Additional 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:
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Polymorphism, genetic Risk factors Carotid Artery, Internal, Dissection Vertebral Artery Dissection |
Genetic predisposition Outcome Therapy |
Additional relevant MeSH terms:
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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 May 22, 2013