Status:
ACTIVE_NOT_RECRUITING
Biomarkers of CASH
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Mayo Clinic
University of California, San Francisco
Conditions:
Cerebral Cavernous Malformation
Cavernous Angioma
Eligibility:
All Genders
18+ years
Brief Summary
The project aims to develop prognostic and diagnostic blood tests for symptomatic brain hemorrhage in patients diagnosed with cavernous angiomas, a critical clinical challenge in a disease affecting m...
Detailed Description
Cerebral cavernous angioma (CA) is a capillary microangiopathy affecting more than a million Americans, predisposing them to a premature risk of brain hemorrhage. Fewer than 200,000 cases who have suf...
Eligibility Criteria
Inclusion
- Aim 1 and 2:
- Clinical diagnosis of CA
- age 18 or older
- solitary or multiple
- familial or sporadic
- with or without prior symptoms
Exclusion
- Prior excision of a solitary CA lesion
- prior stereotactic radiosurgery or any brain irradiation
- spinal cavernoma without brain lesion
- other brain pathology unrelated to CA (demyelinating disease, brain tumor)
- seizures or stroke unrelated to CA in the prior year
- current pregnancy or within 6 months postpartum
- reluctance to undergo venipuncture or donate blood specimen, or be called for clinical follow-up for up to one year
- homeless or incarcerated persons, or other reason a subject will be unable/unlikely to be reached for follow-up
- Aim 3:
- Inclusion Criteria:
- \< 30 years of age
- one or more seizures (with or without medical therapy) in the prior year
- OR
- \> 50 years of age
- having received an MRI of the brain with SWI (susceptibility weighted imaging) sequences for any indication in the year prior to enrollment
- No HMA on brain MRI SWI sequences
- OR
- \> 50 years of age
- having received an MRI of the brain with SWI sequences for any indication in the year prior to enrollment
- Two or more microbleeds on SWI brain MRI sequences, adjudicated by neuroradiologist
Key Trial Info
Start Date :
May 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
1040 Patients enrolled
Trial Details
Trial ID
NCT04467489
Start Date
May 22 2020
End Date
June 30 2026
Last Update
August 11 2025
Active Locations (4)
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1
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
2
University of California, San Francisco
San Francisco, California, United States, 94117
3
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
4
Mayo Clinic
Rochester, Minnesota, United States, 55905