Principal Investigator: Jennifer Majersik
Keywords: Cavernous Angiomas , Hemorrhage , Symptomatic , Observational , Cerebral Cavernous Malformations , Stroke Department: Neurology
IRB Number: 00110074
Specialty: Neurosurgery, Neurosurgery, Neurology, Neurology
Sub Specialties: Neurovascular Surgery, Vascular Malformations, Stroke , Vascular Neurology
Recruitment Status: Recruiting

Contact Information

Julia Darling

Brief Summary

 Aim 1: To assess enrollment rates, harmonize data and determine baseline characteristics of cavernous angiomas with symptomatic hemorrhage (CASH)

Aim 2: Test feasibility, accuracy, precision and reproducibilty of MRI bio-marker measurements at multiple sites. N/A for Utah

Aim 3: To assess rates of symptomatic hemorrhage and changes in bio-markers and functional status and quality of life measures during prospective follow-up. N/A at Utah

Specific milestones are proposed and go/no-go decisions based on interim analyses and results of these aims.  Data from this project will insure the most stringent rigor in trial assumptions, including validated enrollment rates and baseline features specific to CASH.  Results will endorse or reject outcome instruments or biomarkers based on empiric observations, hypothesizing a clinically meaningful impact of putative therapies.   

Inclusion Criteria

Inclusion Criteria:

(1) 18 years of age and older

(2) diagnosed with a brain CA (single or multiple)

(3) had a SH within the past year (with demonstrated new lesional bleeding or hemorrhagic growth on diagnostic studies AND attributable new symptoms)

(4) no prior treatment of the symptomatic lesion (after neurosurgical consultation).

Exclusion Criteria

Exclusion Criteria:

(1) have symptomatic spinal CA’s

(2) have received prior brain irradiation. 

(3) cases where verification of SH with clinical and imaging review cannot be accomplished.

U of Utah is not an FUBV site, please ignore FUBV excl criteria from main protocol.