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Cerebral Oxygen Metabolism in Children (COMIC)

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: NCT04157179
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

The purpose of this research study is to better understand how blood flow and metabolism change can influence brain development in the early decades of life.

We will examine brain blood flow and metabolism using magnetic resonance imaging (MRI). The brain's blood vessels expand and constrict to regulate blood flow based on the brain's needs. The amount of expanding and contracting the blood vessels can do varies by age. The brain's blood flow changes in small ways during everyday activities, such as normal brain growth, exercise, or deep concentration. Significant illness or psychological stress may increase the brain's metabolic demand or cause other bigger changes in blood flow. If blood vessels are not able to expand to give more blood flow when metabolic demand is high, the brain may not get all of the oxygen it needs. In extreme circumstances, if the brain is unable to get enough oxygen for a long time, a stroke may occur. Sometimes small strokes occur without other noticeable changes and are only detectable on an MRI. These are sometimes called "silent strokes." In less extreme circumstances, not having as much oxygen as it wants may cause the brain to grow and develop more slowly than it should.

One way to test the ability of blood vessels to expand is by measuring blood flow while breathing in carbon dioxide. Carbon dioxide causes blood vessels in the brain to dilate without increasing brain metabolism.

During this study participants may be asked to undergo a blood draw, MRI, and potential neuropsychological assessments. It is also possible that the study team will use a special mask (RespirACT) to control the amount of carbon dioxide the participants breathe in so they don't breathe in too much.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Cerebral Stroke Other: Carbon Dioxide Not Applicable

Detailed Description:
This is an observational study. The purpose of the study is to identify imaging biomarkers for brain tissue under high metabolic stress at risk for permanent injury. We will measure CBF, OEF, and CVR in children with and without perturbations in cerebral oxygen delivery over time to determine each parameter's role in clinical and radiologic neurologic outcomes. Measuring CBF and OEF can be done with specialized MRI sequences. Measuring CVR requires a vasoactive response, such as carbon dioxide. In order to delivery carbon dioxide evenly and as safely as possible, we will use RespirACT, an MRI-compatible device, to prevent over-breathing carbon dioxide and allow rapid steady-state physiology to minimize total scan time.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All arms will receive the same study conditions.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cerebral Oxygen Metabolism in Children
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: Healthy Controls Other: Carbon Dioxide
The study team will administer carbon dioxide to the participants through a special mask (RespirACT) at a level

Active Comparator: Extracorporeal Membrane Oxygenation survivors Other: Carbon Dioxide
The study team will administer carbon dioxide to the participants through a special mask (RespirACT) at a level

Active Comparator: Sickle Cell Anemia participants Other: Carbon Dioxide
The study team will administer carbon dioxide to the participants through a special mask (RespirACT) at a level




Primary Outcome Measures :
  1. Cerebral Oxygen Metabolism [ Time Frame: From the beginning of the MRI scan to the completion of the MRI scan -- 75 minutes. ]

Secondary Outcome Measures :
  1. Cerebrovascular Reactivity [ Time Frame: From administration of carbon dioxide to end of inhalation of carbon dioxide -- 15 minutes. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Healthy Controls:

  • Healthy controls ages 3-30 years of age
  • Able to participate in MRI scan without sedation
  • Not currently pregnant
  • Not on stimulant medications
  • No psychiatric history, as defined by seeing a psychiatrist for medical evaluation and treatment
  • No seizure history
  • No history of stroke or cerebrovascular disease
  • May have occasional headaches if not taking a daily preventative medication for headaches
  • Not on vasodilatory medication, such as sildenafil or verapamil

Sickle Cell Anemia Participants:

  • Ages 3-30 years of age
  • Hb SS or SBeta-thal
  • Able to participate in MRI scan without sedation
  • Not currently pregnant
  • Not on stimulant medications
  • Not on vasodilatory medication, such as sildenafil or verapamil

Extracorporeal Membrane Oxygenation (ECMO) Survivors:

  • Ages 3-30 years of age
  • History of cannulation for ECMO
  • Able to participate in MRI scan without sedation
  • Not currently pregnant
  • Not on stimulant medications
  • Not on vasodilatory medication, such as sildenafil or verapamil

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): NCT04157179


Contacts
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Contact: Madison Streb, BA 3142730828 m.streb@wustl.edu
Contact: Kristin Guilliams, MD 3144546120 kristinguilliams@wustl.edu

Locations
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United States, Missouri
Washington University of St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Madison Streb, BA    314-273-0828    m.streb@wustl.edu   
Contact: Kristin Guilliams, MD    3144546120    kristinguilliams@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04157179    
Other Study ID Numbers: 201905044
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Washington University School of Medicine:
extracorporeal membrane oxygenation
Additional relevant MeSH terms:
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Stroke
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases