Developing blood tests for brain hemorrhage in cavernous angiomas

Biomarkers of Cerebral Cavernous Angioma With Symptomatic Hemorrhage (CASH)

This study is testing new blood tests to see if they can help diagnose and predict bleeding in the brain for people with cavernous angiomas.

Quick facts

• Study type: Observational
• Enrollment: 1040 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Chicago (Academic / other)
• Locations: 4 sites (Phoenix, Arizona and 3 other locations)
• Trial ID: NCT04467489 on ClinicalTrials.gov

What this trial studies

This project aims to create prognostic and diagnostic blood tests for patients with symptomatic brain hemorrhage caused by cavernous angiomas, a condition affecting over a million Americans. It investigates whether blood biomarkers can enhance the accuracy of advanced imaging techniques in assessing lesional bleeding. The study employs a novel integrational approach to biomarker development, focusing on the underlying mechanisms of cerebrovascular disease and their clinical implications. By optimizing these biomarkers, the research seeks to improve diagnosis, predict future hemorrhagic events, and monitor patient responses to therapy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 or older with a clinical diagnosis of cavernous angioma, regardless of prior symptoms.

Not a fit: Patients with prior brain surgery, unrelated brain pathology, or those unable to participate in follow-up may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and accessible diagnostic tools for patients at risk of brain hemorrhage.

How similar studies have performed: Other studies have shown promise in using biomarkers for similar conditions, but this approach is innovative in its specific focus on cavernous angiomas.

Eligibility criteria

Aim 1 and 2:

Inclusion Criteria:

1. Clinical diagnosis of CA
2. age 18 or older
3. solitary or multiple
4. familial or sporadic
5. with or without prior symptoms

Exclusion Criteria:

1. Prior excision of a solitary CA lesion
2. prior stereotactic radiosurgery or any brain irradiation
3. spinal cavernoma without brain lesion
4. other brain pathology unrelated to CA (demyelinating disease, brain tumor)
5. seizures or stroke unrelated to CA in the prior year
6. current pregnancy or within 6 months postpartum
7. reluctance to undergo venipuncture or donate blood specimen, or be called for clinical follow-up for up to one year
8. homeless or incarcerated persons, or other reason a subject will be unable/unlikely to be reached for follow-up

Aim 3:

Inclusion Criteria:

1. \< 30 years of age
2. one or more seizures (with or without medical therapy) in the prior year

OR

1. \> 50 years of age
2. having received an MRI of the brain with SWI (susceptibility weighted imaging) sequences for any indication in the year prior to enrollment
3. No HMA on brain MRI SWI sequences

OR

1. \> 50 years of age
2. having received an MRI of the brain with SWI sequences for any indication in the year prior to enrollment
3. Two or more microbleeds on SWI brain MRI sequences, adjudicated by neuroradiologist

Exclusion Criteria:

1. concurrent brain disease or structural brain pathology
2. medical illness requiring hospitalization or surgery, seizure or stroke in the prior 12 months
3. active use of prescription medications in the prior 12 months
4. current pregnancy or within 6 months postpartum
5. reluctance to undergo venipuncture or donate blood specimen

OR

1. concurrent brain disease or structural brain pathology
2. medical illness requiring hospitalization or surgery, or stroke in the prior 12 months other than seizure disorder
3. active use of prescription medications in the prior 12 months except anticonvulsants
4. current pregnancy or within 6 months postpartum
5. reluctance to undergo venipuncture or donate blood specimen

OR

1. concurrent brain disease or structural brain pathology
2. medical illness requiring hospitalization or surgery within the prior year
3. any history of stroke or epileptic seizure within the prior year
4. current pregnancy or within 6 months postpartum
5. reluctance to undergo venipuncture or donate blood specimen

OR

1. concurrent brain disease or structural brain pathology
2. medical illness requiring hospitalization or surgery within the prior year
3. any history of stroke or epileptic seizure within the prior year
4. current pregnancy or within 6 months postpartum
5. reluctance to undergo venipuncture or donate blood specimen

Where this trial is running

Phoenix, Arizona and 3 other locations

• Barrow Neurological Institute at St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States (Active_not_recruiting)
• University of California, San Francisco — San Francisco, California, United States (Active_not_recruiting)
• The University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Active_not_recruiting)

Study contacts

• Principal investigator: Issam Awad, MD — University of Chicago
• Study coordinator: Agnieszka Stadnik, MS

Conditions Cerebral Cavernous Malformation; Cavernous Angioma; Hemorrhagic Microangiopathy; plasma biomarker; imaging biomarker; machine learning