Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05298709
Other study ID # 21-136
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 15, 2023
Est. completion date June 28, 2025

Study information

Verified date June 2024
Source University of New Mexico
Contact Michel Tobey, MD
Phone (505) 272-3152
Email MTorbey@salud.unm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal is to characterize vascular reactivity and cardiac pulsatility of normal appearing white matter in patients with CCM during hypercarbia/hypocarbia using quantitative real-time high-speed multi-echo fMRI to develop prognostic biomarkers for CCM formation


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date June 28, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. All familial CCM subjects presenting at UNMH who can consent to our study. 2. Adult Male/Female patients ages >18 years old Exclusion Criteria: 1. Individuals ages <18 year 2. Subjects with a known fear of dyspnea or enclosed spaces will be excluded from this study as well as those with metal implants, COPD, heart conditions, and hypercapnia. 3. Subjects who have contraindications to MRI such as harboring incompatible ferromagnetic objects implanted in the body. 4. Pregnant women (screening for pregnancy will be performed by oral questionnaire. MRI is safe in pregnancy but the study will exclude pregnant subjects, as the effects of respiratory challenge cannot be predicted in such subjects. Since these effects are proportional to the stage of gestation, oral history will be sufficient to assure safety.) 5. Prisoners. 6. People unable to consent. 7. People unable to participate due to prior neurological deficits. 8. Subjects with underlying pre-existing pulmonary illness; such as asthma, COPD, pulmonary hypertension, will be excluded. 9. Cognitively impaired and/or participants not able to speak English language will not be included in the study (This pilot study involves performing motor and verbal tasks while in the MRI, in addition to undergoing a respiratory challenge, that requires understanding instructions clearly. We do not have current capabilities to include a translator who would be available at all stages of the study to include subjects who do not speak English.)

Study Design


Intervention

Other:
Hyperventilation and CO2 challenge
Subjects will also be asked to complete hyperventilation and CO2 breathing tasks based on instruction from the study investigators as described in study arm.

Locations

Country Name City State
United States University of New Mexico Neurology Research Center Albuquerque New Mexico

Sponsors (2)

Lead Sponsor Collaborator
University of New Mexico University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemodynamic Response Primary end point of the study is to measure the amplitude and frequency response of hemodynamic response function during hypercarbia/hypocarbia using task-based functional MRI 12 Months
Primary Resting state connectivity To measure the strength of resting-state connectivity during hypercarbia/hypocarbia using high-speed multi-echo resting-state functional MRI. 12 month
Secondary Cardiac Pulsatility Measure the amplitude and frequency spectrum of the cardiac pulsatility during hypercarbia/hypocarbia in functional MRI time series that are acquired using high-speed multi-echo functional MRI 12 Months
Secondary First Harmonic To measure the amplitude ratio of the first harmonic of the cardiac pulsatility relative to the cardiac base frequency in these data, which is a biomarker of vascular compliance.speed multi echo fMRI. 12 Months
See also
  Status Clinical Trial Phase
Recruiting NCT04467489 - Biomarkers of CASH
Active, not recruiting NCT05085561 - The Symptomatic Cerebral Cavernous Malformation Trial of REC-994 Phase 2
Active, not recruiting NCT02946866 - CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study
Active, not recruiting NCT02603328 - Atorvastatin Treatment of Cavernous Angiomas With Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) Trial Phase 1/Phase 2
Terminated NCT05148663 - CCM Blood Biomarker Validation Study
Completed NCT03652181 - CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness
Completed NCT03589014 - Treat_CCM: Propranolol in Familial Cerebral Cavernous Malformation Phase 2