Clinical trial NCT02756091: International Intracranial Dissection Study
Official title: International Intracranial Artery Dissection Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebrovascular Disorders
Vascular: Intracranial
Intimal Dissection
Stroke
Keywords: Intracranial Artery Dissection
IAD
Stroke
Observational Study
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss Heart Foundation
name: Cervical Artery Dissections and Ischemic Stroke Patients - Consortium
First posted: 2016-04-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are recruited in a consecutive ongoing recruitment process in daily clinical practice.

Patients who are hospitalized in participant sites are screened by authorized study group members according to local daily practice. If the patient matches the selection criteria (inclusion and exclusion criteria)he/she is enrolled in the study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Rankin Scale score (mRS score)
timeFrame: 180 days after diagnosis +/- 30 days
measure: Recurrence of stroke
timeFrame: 180 days after diagnosis
Secondary outcomes:
measure: Recurrence of cervico- cerebral dissection
timeFrame: 90 days, 180 days, 12 months
measure: Recurrence of stroke
timeFrame: 0-10 days, 90 days, 12 months after diagnosis
measure: Change in Modified Rankin Scale score (mRS score) from before diagnosis to follow up
timeFrame: 0-10 days, 90 days, 12 months after diagnosis
measure: Change in occupational status from before diagnosis to follow up
timeFrame: 0-10 days, 90 days, 180 days, 12 months after diagnosis
measure: Mortality
timeFrame: 0-10 days, 90 days, 180 days, 12 months after diagnosis
measure: Increase or reduction in size (>50% local degree of stenosis) or disappearance of stenosis at 6 months (in patients with stenotic and occlusive dissection)
timeFrame: 180 days after diagnosis
measure: Increase or reduction in size (> 20% maximal diameter) of aneurysms at 6 months (in patients with aneurysm)
timeFrame: 180 days after diagnosis
Other outcomes:
measure: Personal and familiar risk factors for intracranial artery dissection
timeFrame: 0-10 days after diagnosis
measure: Laboratory parameters assessed by blood test
timeFrame: 90 days, 180 days, 12 months
measure: Radiological findings assessed by magnetic resonance imaging (MRI), magnetic resonance angiography, computed tomography (CT), computed tomography angiography, digital subtraction angiography or duplex sonography
timeFrame: 0-10 days, 90 days, 180 days, 12 months after diagnosis
measure: Localization of intracranial artery dissection
timeFrame: 0-10 days after diagnosis
measure: Demographic variables
timeFrame: 0-10 days after diagnosis
Locations:
city: Osaka
country: Japan
facility: National Cerebral and Cardiovascular Center Osaka
state: Kansai
city: Basel
country: Switzerland
facility: Department of Neurology, University Hospital Basel
state: Basel- Stadt
city: Bern
country: Switzerland
facility: Department of Neurology, Inselspital Bern
Study officials:
affiliation: Neurology Department, Inselspital University Hospital Bern
name: Marcel Arnold, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology Department, Inselspital University Hospital Bern
name: Barbara Goeggel Simonetti, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: