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International Intracranial Dissection Study

International Intracranial Artery Dissection Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02756091
Acronym
I-IDIS
Enrollment
500
Registered
2016-04-29
Start date
2016-08-31
Completion date
2027-11-30
Last updated
2024-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Disorders, Intimal Dissection, Stroke, Vascular: Intracranial

Keywords

Intracranial Artery Dissection, IAD, Stroke, Observational 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.

Interventions

Sponsors

Swiss Heart Foundation
CollaboratorOTHER
Cervical Artery Dissections and Ischemic Stroke Patients - Consortium
CollaboratorNETWORK
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Rankin Scale score (mRS score)180 days after diagnosis +/- 30 daysThe mRS is a standardised valid measure to semi-quantify functional outcome after stroke.
Recurrence of stroke180 days after diagnosis

Secondary

MeasureTime frameDescription
Change in Modified Rankin Scale score (mRS score) from before diagnosis to follow up0-10 days, 90 days, 12 months after diagnosisThe mRS is a standardised valid measure to semi-quantify functional outcome after stroke.
Recurrence of stroke0-10 days, 90 days, 12 months after diagnosis
Change in occupational status from before diagnosis to follow up0-10 days, 90 days, 180 days, 12 months after diagnosisThe 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.
Mortality0-10 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)180 days after diagnosisAssessed 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)180 days after diagnosisAssessed by radiological assessments according to local routine procedures.
Recurrence of cervico- cerebral dissection90 days, 180 days, 12 months

Other

MeasureTime frameDescription
Localization of intracranial artery dissection0-10 days after diagnosisLocalization of intracranial artery dissection by imaging modalities according to local routine procedures (may differ according to local standard).
Demographic variables0-10 days after diagnosisAssessment 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.
Radiological findings assessed by magnetic resonance imaging (MRI), magnetic resonance angiography, computed tomography (CT), computed tomography angiography, digital subtraction angiography or duplex sonography0-10 days, 90 days, 180 days, 12 months after diagnosisAssessment of radiological findings according to local routine procedures (may differ according to local standard).
Laboratory parameters assessed by blood test90 days, 180 days, 12 monthsAssessment of laboratory findings according to local routine procedures (may differ according to local standard).
Personal and familiar risk factors for intracranial artery dissection0-10 days after diagnosisAssessment 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.

Countries

Japan, Switzerland

Contacts

Primary ContactMarcel Arnold, Prof. Dr. med.
marcel.arnold@insel.ch
Backup ContactBarbara Goeggel Simonetti, Dr. med.
Barbara.GoeggelSimonetti@insel.ch

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026