International Intracranial Dissection Study

NCT02756091 | Recruiting

• 1 other identifier: 2016-00526
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cerebrovascular Disorders; Vascular: Intracranial; Intimal Dissection; Stroke

Keywords

Intracranial Artery Dissection; IAD; Stroke; Observational Study

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Recurrence of cervico- cerebral dissection

  90 days, 180 days, 12 months

• 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

Other Outcomes (5)

• 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

Interventions

No study-specific intervention OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with acute Intracranial Artery Dissection (symptom onset ≤ 30 days)
• Age ≥ 18 years
• Consent to participate according to local requirements

You may not qualify if:

• Iatrogenic dissection caused by endovascular intervention
• Extracranial dissection with intracranial extension

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss Heart Foundation: collaborator
• Cervical Artery Dissections and Ischemic Stroke Patients - Consortium: collaborator

Study Sites (3)

National Cerebral and Cardiovascular Center Osaka

Osaka, Kansai, 565-8565, Japan

RECRUITING

Department of Neurology, University Hospital Basel

Basel, Canton of Basel-City, 4056, Switzerland

RECRUITING

Department of Neurology, Inselspital Bern

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Cerebrovascular Disorders; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marcel Arnold, Prof. Dr. med.

  Neurology Department, Inselspital University Hospital Bern

  PRINCIPAL INVESTIGATOR

• Barbara Goeggel Simonetti, Dr. med.

  Neurology Department, Inselspital University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcel Arnold, Prof. Dr. med.

CONTACT

marcel.arnold@insel.ch

Barbara Goeggel Simonetti, Dr. med.

CONTACT

Barbara.GoeggelSimonetti@insel.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 29, 2016
• Study Start: August 1, 2016
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

JP (1); CH (2)