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Functional Magnetic Resonance Imaging (fMRI) Vascular Reactivity in Cerebral Cavernous Malformations (CCM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05298709
Recruitment Status : Not yet recruiting
First Posted : March 28, 2022
Last Update Posted : March 28, 2022
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
University of New Mexico

Brief 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

Condition or disease Intervention/treatment
Cerebral Cavernous Malformation Other: MRI study session

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Magnetic Resonance Imaging (fMRI) Vascular Reactivity in Cerebral Cavernous Malformations (CCM)
Estimated Study Start Date : April 1, 2022
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : June 30, 2023



Intervention Details:
  • Other: MRI study session
    The MRI study sessions will be approximately 1 to 1.5 hours duration. Resting state fMRI will be performed using either eyes open or eyes closed condition while relaxing as much as possible without moving and thinking of anything. Task-based fMRI will be performed using specific study defined tasks. Subjects will also be asked to complete hyperventilation and CO2 breathing tasks based on instruction from the study investigators.


Primary Outcome Measures :
  1. Vascular reactivity [ Time Frame: 12 Months ]
    Primary end point of the study is to characterize the vascular reactivity in normal appearing white matter of cerebral cavernoma patients.


Secondary Outcome Measures :
  1. Cavernomas during hypercarbia/ hypocarbia states [ Time Frame: 12 Months ]
    The characterization of these cavernomas during hypercarbia/ hypocarbia states.

  2. Measurement of the cardiac pulsatility [ Time Frame: 12 Months ]
    Measurement of the cardiac pulsatility during hypercarbia/ hypocarbia states, using high speed multi echo fMRI.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients already diagnosed with familial CCM. Suitable patients coming in the UNM CCM clinic will be contacted and requested to be a part of the study.
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05298709


Contacts
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Contact: Javed Khader Eliyas, MD (505) 272-3160 JkEliyas@salud.unm.edu
Contact: Jacquelyn Morales 5052720356 jsmorales@salud.unm.edu

Sponsors and Collaborators
University of New Mexico
University of California, San Francisco
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Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT05298709    
Other Study ID Numbers: 21-136
First Posted: March 28, 2022    Key Record Dates
Last Update Posted: March 28, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There would not be any plans in place to share IPD. All data will be de-identified and not linked to any individual participant.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemangioma, Cavernous, Central Nervous System
Congenital Abnormalities
Hemangioma, Cavernous
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Central Nervous System Vascular Malformations
Nervous System Malformations
Nervous System Diseases
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Hemostatic Disorders
Vascular Diseases
Hemorrhagic Disorders
Hematologic Diseases