N/A
N=123
CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness
CCM · Cavernoma · Cerebral Cavernous Malformation · Cerebral Cavernous Malformations 1 · Cerebral Cavernous Malformations 2
Bottom Line
View on ClinicalTrials.gov: NCT03652181 ↗Enrolled (actual)
123
Serious AEs
—
Results posted
Jun 2024
Primary outcome: Primary: Rate of Recurrent Symptomatic Hemorrhage During the Two Year Follow-up Period in Patients With CASH. — 10; 11 Number of new bleeds
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Recurrent Symptomatic Hemorrhage During the Two Year Follow-up Period in Patients With CASH. |
10; 11 | — |
| SECONDARY Percent Change in QSM Value (Lesional Iron Content) |
16.33; 19.61 | 0.033 sig |
| SECONDARY Percent Change in Contrast-enhanced Quantitative Perfusion (DCEQP) Value (Vascular Permeability) |
61.62; 52.45 | 0.3459 |
| SECONDARY Compare the Number of Patients With MRS 2 or Higher Who Had Prospective Symptomatic Hemorrhage to Those With MRS 2 or Higher Without Prospective Symptomatic Hemorrhage During the 2 Year Follow-up Period. |
1; 2; 27; 15 | 1.0 |
| SECONDARY Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period. |
117; 97; 61; 5; 1; 0 | — |
| SECONDARY Median Score of European Quality of Life Visual Analogue Scale (EQ-VAS) During the 2 Year Follow-up Period. |
80; 80; 80 | — |
| SECONDARY Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Mobility" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. |
83; 69; 44; 40; 33; 24 | — |
| SECONDARY Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Self-care" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. |
111; 95; 63; 12; 7; 5 | — |
| SECONDARY Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Usual Activities" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. |
72; 66; 50; 50; 34; 17 | — |
| SECONDARY Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Pain / Discomfort" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. |
63; 63; 48; 51; 36; 19 | — |
| SECONDARY Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Anxiety / Depression" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. |
72; 62; 49; 46; 38; 19 | — |
| SECONDARY Median T-score for "Anxiety" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. |
53.7; 51.2; 51.2 | — |
| SECONDARY Median T-score for "Depression" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. |
41.0; 41.0; 41.0 | — |
| SECONDARY Median T-score for "Fatigue" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. |
48.6; 48.6; 46.0 | — |
| SECONDARY Median T-score for "Pain" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. |
49.6; 49.6; 41.6 | — |
| SECONDARY Median T-score for "Sleep Disturbance" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. |
50.5; 50.5; 50.5 | — |
| SECONDARY Median T-score for "Social" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. |
51.9; 51.9; 64.2 | — |
| SECONDARY Median T-score for "Physical Function" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. |
56.9; 56.9; 56.9 | — |
Summary
Brain Cavernous Angiomas with Symptomatic Hemorrhage (CASH) are rare, but they exact a heavy burden of neurologic disability from recurrent bleeding, for which there is no proven therapy. This trial readiness project aims to address current critical obstacles in identifying cases at multiple sites, characterizing their relevant features, and measuring their outcome. The timing cannot be more opportune, with therapeutic targets already identified, exceptional collaboration among researchers and with the patient community, and several drugs ready to benefit from a track to clinical testing in the next five years.
Eligibility Criteria
Inclusion Criteria
- 18 years of age and older
- Diagnosed with a brain CA (single or multiple)
- Had a SH within the past year (with demonstrated new lesional bleeding or hemorrhagic growth on diagnostic studies AND attributable new symptoms)
- Subject is able to provide informed consent
Exclusion Criteria
- Spinal CA as source of SH
- Prior brain irradiation
- Cases where verification of SH with clinical and imaging review cannot be accomplished
- Prior or planned treatment of the symptomatic lesion (after neurosurgical consultation)
To be eligible for Aims 2 and 3, CASH cases enrolled in Aim 1 will be further excluded from follow-up and baseline validation (FUBV) for the following reasons:
- Contraindication for administration of contrast agent or otherwise unwilling or unable to undergo research MRI studies
- Pregnant or breastfeeding women
- Homeless or incarcerated persons, or other reason a subject will be unable/unlikely to return for follow-up visits
Data sourced from ClinicalTrials.gov (NCT03652181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.