Cervical Artery DissectionCADISPNCT00657969
Looking For Genetic and Environmental Risk Factors and Therapeutic Aspects in Cervical Artery Dissections
An observational study of Cervical Artery Dissection and Stroke, run by Cervical Artery Dissections and Ischemic Stroke Patients - Consortium at 24 sites in 9 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Artery Dissection, Stroke, Brain Infarction
- How many people
- 4,169 participants
- Where
- 24 sitesin 9 countries
- Study dates
- Jul 2005to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: groups 1 and 2: hospital-based, neurology departments group 3: community samples
Who may be able to join
- 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
- 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
- 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
Who cannot join
- 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:
- Possible cerebral ischemia but normal cerebral imaging
- CAD cannot be ruled out (e.g.persistent arterial occlusion without mural hematoma)
Show all 12Show fewer
- 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:
Trial locations and contacts
24 sites in 9 countries.
24 sites in 9 countries
France7 sites
Department of Neurology, University Hospital of Amiens
Amiens, 80000
Department of Neurology, University Hospital of Besançon
Besançon, 25000
Department of Neurology, University Hospital of Dijon
Dijon, 21000
Department of Neurology, University Hospital of Lille
Lille, 59000
Inserm U744 Institut Pasteur de Lille
Lille, 59000
Department of Neurology, University Hospital Pitié-Salpêtrière
Paris, 75013
Department of Neurology, University Hospital Sainte-Anne
Paris, 75015
Italy6 sites
Department of Neurology, University Hospital of Brescia
Brescia, 25100
Department of Neurology, Ospedale Maggiore Policlinico di Milano
Milan, 20100
Ospedale Milano San Raffaele
Milan, 20132
Department of Neurology, University Hospital Milano-Bicocca
Monza, 20052
Department of Neurology, University Hospital of Perugia
Perugia, 06081
Rehabilitation Center, IRCCS Santa Lucia, Roma
Rome, 00100
Germany4 sites
Rehabilitation Center, Schmieder-Klinik
Heidelberg, 62120
Department of Neurology, University Hospital of Heidelberg
Heidelberg, 69120
Department of Neurology, Hospital of Ludwigshafen
Ludwigshafen, 67063
Department of Neurology, University Hospital of Munich
Munich, 81377
Belgium2 sites
Department of Neurology, University Hospital of Brussels (ULB)
Brussels, 1070
Department of Neurology, University Hospital of Leuven
Leuven, 3000
Finland1 site
Department of Neurology, Helsinki University Central Hospital
Helsinki, 00290
Switzerland1 site
Department of Neurology, University Hospital of Basel
Basel, 4031
Turkey (Türkiye)1 site
Department of Neurology, Cerrahpasa Medical Faculty, Istanbul University
Istanbul
United Kingdom1 site
Department of Neuroscience, St George's University Hospital of London
London, SW170RE
About this study
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
Read the 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.
- Conditions
- Cervical Artery Dissection, Stroke, Brain Infarction
- Keywords
- Polymorphism, genetic, Risk factors, Carotid Artery, Internal, Dissection, Vertebral Artery Dissection, Genetic predisposition, Outcome, Therapy
- Medical subject headings
- Stroke, Brain Infarction, Carotid Artery, Internal, Dissection, Vertebral Artery Dissection, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
association of genetic polymorphisms with cervical artery dissections
Measured: 2009
Secondary outcomes (2)
association of environmental risk factors with cervical artery dissections
Measured: 2009
gene-environment interactions
Measured: 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startJul 2005
- Primary completionJan 2009
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Artery DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 4,169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cervical Artery Dissections and Ischemic Stroke Patients - Consortium
- Sponsor type
- Research network
- Investigators
- Stéphanie Debette, MD, PhD, Study director, Department of Neurology (EA2691), University Hospital of Lille; Inserm, U744, Pasteur Institute, Lille, FranceCaspar Grond-Ginsbach, PhD, Study chair, Department of Neurology, University Hospital of Heidelberg, GermanyDidier Leys, MD PhD, Principal investigator, Department of Neurology (EA2691), University Hospital of Lille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657969
- Sponsor's protocol ID
- CADISP
- Acronym
- CADISP
- Status last verified
- Oct 2009
- First submitted
- 8 Apr 2008
- Last updated
- 21 Oct 2009
- Results posted
- No
Publications
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.
PubMed 17656656Debette 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.
PubMed 19659826
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Looking For Genetic and Environmental Risk Factors and Therapeutic Aspects in Cervical Artery Dissections
- ClinicalTrials.gov ID
- NCT00657969
- Acronym / sponsor ID
- CADISP / CADISP
- Conditions
- Cervical Artery Dissection, Stroke, Brain Infarction
- Keywords
- Polymorphism, genetic, Risk factors, Carotid Artery, Internal, Dissection, Vertebral Artery Dissection, Genetic predisposition, Outcome, Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,169 participants (actual)
- Lead sponsor
- Cervical Artery Dissections and Ischemic Stroke Patients - ConsortiumResearch network
- Study start
- Jul 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Sep 2009 (estimated)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- groups 1 and 2: hospital-based, neurology departments group 3: community samples
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (12 listed)
- Purely intracranial dissection
- Dissection occurring after an endovascular procedure
- Known mendelian genetic disorder that can explain the dissection (e.g. vascular Ehlers-Danlos syndrome)
- Possible cerebral ischemia but normal cerebral imaging
- CAD cannot be ruled out (e.g.persistent arterial occlusion without mural hematoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
association of genetic polymorphisms with cervical artery dissections
Time frame: 2009
2 secondary outcomes
association of environmental risk factors with cervical artery dissections
Time frame: 2009
gene-environment interactions
Time frame: 2009
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2009.
- Background: PubMed 17656656Engelter 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.
- Background: PubMed 19659826Debette 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie Debette, MD, PhD study director
Department of Neurology (EA2691), University Hospital of Lille; Inserm, U744, Pasteur Institute, Lille, France
Caspar Grond-Ginsbach, PhD study chair
Department of Neurology, University Hospital of Heidelberg, Germany
Didier Leys, MD PhD principal investigator
Department of Neurology (EA2691), University Hospital of Lille, France
24 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Artery Dissection and Stroke, run by Cervical Artery Dissections and Ischemic Stroke Patients - Consortium at 24 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France, Italy, Germany, Belgium, Argentina and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association of genetic polymorphisms with cervical artery dissections (time frame: 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00657969, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2009; AzTrials last refreshed its copy on 26 Oct 2026.