NCT Number: NCT02756091
International Intracranial Dissection Study
Cervicocerebral artery dissection is a major cause for stroke in young adults. While knowledge of cervical artery dissection (CeAD) has increased thanks to a number of high quality studies, knowledge on intracranial artery dissection (IAD) is limited. Due to treatment and publication bias little is known about the natural history of IAD. Overall, IAD is assumed to have a more severe course than CeAD, with a more ominous outcome in patients with subarachnoid hemorrhage (SAH). Furthermore, little information is available on the risk of recurrent IAD as well as on the risk of recurrent ischemic and haemorrhagic events in non-Asian patients. Radiological diagnosis of IAD can be challenging given the small size of intracranial arteries, and the subtle and non-specific radiological signs which tend to evolve over time. The optimal treatment of IAD is unknown. There are no randomised trials and only observational studies with relatively small sample sizes are available, thus providing a very low level of evidence.
Finding the factors that are decisive for outcome and recurrence after intracranial artery dissection is key to an improved management of this potentially severe disease predominantly affecting young patients. By using standardised protocols for diagnosis, imaging and follow-up, the investigators intend to obtain large representative patient samples in order to fill the gap of evidence.
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
National Cerebral and Cardiovascular Center Osaka, Osaka, Kansai, Japan
About this study
Cervicocephalic artery dissection corresponds to a hematoma in the wall of a cervical or an intracranial artery and is an important cause of stroke in children and young and middle-aged adults. While extracranial cervical artery dissection (CeAD) has been extensively studied and described, less information is available on pure intracranial artery dissection (IAD) not involving the cervical portion of the artery. Early reports were based exclusively on autopsy series, hence biased towards the most severe cases. The incidence of IAD is unknown, but is probably lower than the incidence of symptomatic CeAD in populations of European origin. The proportion of IAD among all cervicocephalic dissections varies substantially between ethnic and age groups, and depending on study recruitment strategies and ascertainment methods. Indeed, recruitments through departments of neurology are biased towards CeAD and IAD presenting with local symptoms and/or ischaemic stroke while recruitments through departments of neurosurgery or interventional neuroradiology are biased towards IAD presenting with subarachnoid haemorrhage (SAH).Therefore, patients with IAD are managed not only by neurologists, but also by neurosurgeons, and interventional neuroradiologists, each having an incomplete picture of the disease.
The vast majority of reported series of IAD patients come from Asian countries and IAD affects the posterior circulation more frequently than the anterior circulation in these series. This contrasts with CeAD and saccular intracranial aneurysms, which most commonly affect the anterior circulation. Due to treatment and publication bias little is known about the natural history of IAD. Overall, IAD is assumed to have a more severe course than CeAD, with a more ominous outcome in patients with SAH IAD than in patients with non-SAH IAD. Furthermore, little information is available on the risk of recurrent IAD as well as risk for recurrent ischaemic and haemorrhagic events. Radiological diagnosis of IAD can be challenging given the small size of intracranial arteries, and the subtle and non-specific radiological signs which tend to evolve with time.
The optimal treatment of IAD is unknown. There are no randomised trials and only observational studies with relatively small sample sizes are available, thus providing a very low level of evidence. Patients with SAH IAD are usually treated by surgery or endovascular procedures because up to 40% of the patients experience re-bleeding within the first days after the event. Various surgical and endovascular treatment methods have been proposed for intracranial dissecting aneurysms. When patients are in poor clinical condition or treatment has an unacceptably high complication risk, it can be decided to withhold from surgical or endovascular treatment. In addition, Most non-SAH IAD patients have been treated medically, but the choice of antithrombotic therapy (anticoagulants or antiplatelet agents) has been evaluated neither in randomised trials nor in systematic reviews and meta-analyses of observational data. As a consequence, there is currently no consensus on optimal treatment of IAD.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients with acute Intracranial Artery Dissection (symptom onset ≤ 30 days)
- Age ≥ 18 years
- Consent to participate according to local requirements
Exclusion criteria
- Iatrogenic dissection caused by endovascular intervention
- Extracranial dissection with intracranial extension
Treatment and study plan
Primary outcomes
-
Modified Rankin Scale score (mRS score)
Time frame: 180 days after diagnosis +/- 30 days
The mRS is a standardised valid measure to semi-quantify functional outcome after stroke.
-
Recurrence of stroke
Time frame: 180 days after diagnosis
Secondary outcomes
-
Recurrence of cervico- cerebral dissection
Time frame: 90 days, 180 days, 12 months
-
Recurrence of stroke
Time frame: 0-10 days, 90 days, 12 months after diagnosis
-
Change in Modified Rankin Scale score (mRS score) from before diagnosis to follow up
Time frame: 0-10 days, 90 days, 12 months after diagnosis
The mRS is a standardised valid measure to semi-quantify functional outcome after stroke.
-
Change in occupational status from before diagnosis to follow up
Time frame: 0-10 days, 90 days, 180 days, 12 months after diagnosis
The patients' profession, workload (whether the patient is full time or part time working) and, if the patient is not working, the reason why he or she is not working (e.g. for medical reason) are assessed by patient interview according to local routine procedure.
-
Mortality
Time frame: 0-10 days, 90 days, 180 days, 12 months after diagnosis
-
Increase or reduction in size (>50% local degree of stenosis) or disappearance of stenosis at 6 months (in patients with stenotic and occlusive dissection)
Time frame: 180 days after diagnosis
Assessed by radiological assessments according to local routine procedures.
-
Increase or reduction in size (> 20% maximal diameter) of aneurysms at 6 months (in patients with aneurysm)
Time frame: 180 days after diagnosis
Assessed by radiological assessments according to local routine procedures.
Other outcomes
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Personal and familiar risk factors for intracranial artery dissection
Time frame: 0-10 days after diagnosis
Assessment of personal and familiar risk factors according to local routine procedures (may differ according to local standard). Risk factors will be elicited by patient questionnaire or by questioning of patients' next of kin.
-
Laboratory parameters assessed by blood test
Time frame: 90 days, 180 days, 12 months
Assessment of laboratory findings according to local routine procedures (may differ according to local standard).
-
Radiological findings assessed by magnetic resonance imaging (MRI), magnetic resonance angiography, computed tomography (CT), computed tomography angiography, digital subtraction angiography or duplex sonography
Time frame: 0-10 days, 90 days, 180 days, 12 months after diagnosis
Assessment of radiological findings according to local routine procedures (may differ according to local standard).
-
Localization of intracranial artery dissection
Time frame: 0-10 days after diagnosis
Localization of intracranial artery dissection by imaging modalities according to local routine procedures (may differ according to local standard).
-
Demographic variables
Time frame: 0-10 days after diagnosis
Assessment of demographic variables according to local routine procedures (may differ according to local standard). Demographic variables will be elicited by patient questionnaire or by questioning of patients' next of kin.
Study contacts
Contact information is provided by the study sponsor or research team.
Barbara Goeggel Simonetti, Dr. med.
CONTACT
Marcel Arnold, Prof. Dr. med.
CONTACT
Sponsors and collaborators
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Other
Collaborators
- Cervical Artery Dissections and Ischemic Stroke Patients - Consortium
- Swiss Heart Foundation
Registry information
Official study title
International Intracranial Artery Dissection Study
Acronym: I-IDIS
Important dates
- Study start
- 2016
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Apr 29, 2016
- Registry last updated
- Nov 13, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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