NCT02756091|Recruiting
International Intracranial Dissection Study
I-IDIS
International Intracranial Artery Dissection Study
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I-IDIS
International Intracranial Artery Dissection Study
Sponsor study identifier
Secondary identifiers
NIH
observational
500
2 countries
3
Study Start
August 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 11, 2016
Actual (reported)April 29, 2016
Actual (reported)August 2016
Date type not reportedThis date has not been verified as actual or estimated.
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Modified Rankin Scale score (mRS score)
The mRS is a standardised valid measure to semi-quantify functional outcome after stroke.
180 days after diagnosis +/- 30 days
Recurrence of stroke
180 days after diagnosis
Recurrence of cervico- cerebral dissection
90 days, 180 days, 12 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
National Cerebral and Cardiovascular Center Osaka
Osaka, Kansai, 565-8565, Japan
Department of Neurology, University Hospital Basel
Basel, Canton of Basel-City, 4056, Switzerland
Department of Neurology, Inselspital Bern
Bern, 3010, Switzerland
Marcel Arnold, Prof. Dr. med.
Neurology Department, Inselspital University Hospital Bern
Barbara Goeggel Simonetti, Dr. med.
Neurology Department, Inselspital University Hospital Bern
First Submitted
April 11, 2016
First Posted
April 29, 2016
Study Start
August 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 30, 2026
EstimatedStudy to Validate the Effects of an Outpatient Secondary Prevention Program for Stroke Victims
Recurrence of stroke
0-10 days, 90 days, 12 months after diagnosis
Change in Modified Rankin Scale score (mRS score) from before diagnosis to follow up
0-10 days, 90 days, 12 months after diagnosis
Change in occupational status from before diagnosis to follow up
0-10 days, 90 days, 180 days, 12 months after diagnosis
Mortality
0-10 days, 90 days, 180 days, 12 months after diagnosis
Personal and familiar risk factors for intracranial artery dissection
0-10 days after diagnosis
Laboratory parameters assessed by blood test
90 days, 180 days, 12 months
Radiological findings assessed by magnetic resonance imaging (MRI), magnetic resonance angiography, computed tomography (CT), computed tomography angiography, digital subtraction angiography or duplex sonography
0-10 days, 90 days, 180 days, 12 months after diagnosis
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 13, 2024
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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