Intracranial Atherosclerotic Stenosis (ICAS), Stroke
Conditions
Keywords
MRI, Stroke, intracranial atherosclerotic stenosis (ICAS)
Brief summary
CAPTIVA-MRI is an observational multimodal MR imaging study that is ancillary to the CAPTIVA trial \[a 3-arm, double-blind Phase III trial conducted at approximately 115 StrokeNet sites randomizing patients with stroke attributed to 70-99% intracranial atherosclerotic stenosis (ICAS) to aspirin plus ticagrelor, clopidogrel, or rivaroxaban.\] The primary goal of this ancillary study is to determine if MRI biomarkers can potentially identify ICAS patients who fail best medical management. The CAPTIVA-MRI study leverages the CAPTIVA trial design and implementation to capture information that will inform and facilitate the next generation of ICAS trials and the management of patients with ICAS.
Interventions
OTHERMRI
Additional MRI to the CAPTIVA study at baseline and 12 months follow-up
Sponsors
Yale University
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enrollment in the CAPTIVA trial: nondisabling symptomatic ischemic infarct stroke within 30 days secondary to 70-99% stenosis of the intracranial ICA, MCA, BA or VA * Ability to obtain baseline study MRI within 14 days of CAPTIVA enrollmen
Exclusion criteria
* Unable or unwilling to undergo MRI, including pacemaker or other MRI contraindications per American College of Radiology guidelines62 * Gadolinium contrast allergy or acute or chronic kidney disease with eGFR\<30 ml/min/1.73m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establish ICAS hemodynamic and plaque MRI biomarkers as reliable predictors of recurrent ischemic stroke in the vascular territory of the index stroke. | 12 months | Recurrent ischemic stroke, defined as symptomatic infarct in the vascular territory of the index stroke artery. This outcome is centrally adjudicated in CAPTIVA using an American Heart Association definition of ischemic stroke |
Countries
United States
Contacts
CONTACTKa-Ho Wong
CONTACTAmy Sulken
PRINCIPAL_INVESTIGATORDavid Liebeskind, MD
University of California, Los Angeles
PRINCIPAL_INVESTIGATORSepideh Amin-Hanjani, MD
University Hospitals
PRINCIPAL_INVESTIGATORRano Chatterjee, MD
Washington University School of Medicine
PRINCIPAL_INVESTIGATORAdam de Havenon, MD, MS
Yale University
Outcome results
None listed