Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

International Intracranial Dissection Study (I-IDIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02756091
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
Swiss Heart Foundation
Cervical Artery Dissections and Ischemic Stroke Patients - Consortium
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment
Cerebrovascular Disorders Vascular: Intracranial Intimal Dissection Stroke Other: No study-specific intervention

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: International Intracranial Artery Dissection Study
Study Start Date : August 2016
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : May 2022



Primary Outcome Measures :
  1. 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.

  2. Recurrence of stroke [ Time Frame: 180 days after diagnosis ]

Secondary Outcome Measures :
  1. Recurrence of cervico- cerebral dissection [ Time Frame: 90 days, 180 days, 12 months ]
  2. Recurrence of stroke [ Time Frame: 0-10 days, 90 days, 12 months after diagnosis ]
  3. 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.

  4. 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.

  5. Mortality [ Time Frame: 0-10 days, 90 days, 180 days, 12 months after diagnosis ]
  6. 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.

  7. 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 Outcome Measures:
  1. 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.

  2. 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).

  3. 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).

  4. 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).

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756091


Contacts
Layout table for location contacts
Contact: Marcel Arnold, Prof. Dr. med. marcel.arnold@insel.ch
Contact: Barbara Goeggel Simonetti, Dr. med. Barbara.GoeggelSimonetti@insel.ch

Locations
Layout table for location information
Japan
National Cerebral and Cardiovascular Center Osaka Recruiting
Osaka, Kansai, Japan, 565-8565
Principal Investigator: Masatoshi Koga, MD, PHD         
Switzerland
Department of Neurology, University Hospital Basel Recruiting
Basel, Basel- Stadt, Switzerland, 4056
Principal Investigator: Engelter Stefan, Prof. Dr. med.         
Department of Neurology, Inselspital Bern Recruiting
Bern, Switzerland, 3010
Principal Investigator: Marcel Arnold, Prof. Dr. med.         
Principal Investigator: Barbara Goeggel-Simonetti, Dr. med.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss Heart Foundation
Cervical Artery Dissections and Ischemic Stroke Patients - Consortium
Investigators
Layout table for investigator information
Principal Investigator: Marcel Arnold, Prof. Dr. med. Neurology Department, Inselspital University Hospital Bern
Principal Investigator: Barbara Goeggel Simonetti, Dr. med. Neurology Department, Inselspital University Hospital Bern
Additional Information:
Layout table for additonal information
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02756091    
Other Study ID Numbers: 2016-00526
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Keywords provided by University Hospital Inselspital, Berne:
Intracranial Artery Dissection
IAD
Stroke
Observational Study
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases