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Carbon Dioxide for Stroke in Children (COMIC Trial)

N/A
Recruiting
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hb SS or SBeta-thal
Not on vasodilatory medication, such as sildenafil or verapamil
Must not have
No history of epilepsy
No history of stroke or cerebrovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will help researchers learn more about how changes in blood flow and metabolism influence brain development.

Who is the study for?
This trial is for healthy individuals or those with sickle cell anemia, aged 3-50, who can have an MRI without sedation. It's not for pregnant women, people on certain blood flow medications, those with severe psychiatric conditions as determined by the study leader, a history of stroke or epilepsy.
What is being tested?
The study tests how well brain blood vessels can handle increased demand by using carbon dioxide to dilate them during MRI scans. This helps understand oxygen metabolism and its impact on brain development and potential silent strokes in children.
What are the potential side effects?
Potential side effects may include discomfort from wearing a special mask to control carbon dioxide intake and reactions related to the MRI procedure or neuropsychological assessments. Blood draws might cause minor pain or bruising.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have sickle cell disease (Hb SS) or Sβ-thalassemia.
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I am not taking any medication that widens my blood vessels.
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I am between 3 and 50 years old and healthy.
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I am between 3 and 50 years old.
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I can undergo an MRI scan without needing to be sedated.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never had epilepsy.
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I have never had a stroke or brain blood vessel issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Healthy ControlsActive Control1 Intervention
Group II: Extracorporeal Membrane Oxygenation survivorsActive Control1 Intervention
Group III: Sickle Cell Anemia participantsActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,343,908 Total Patients Enrolled

Media Library

Healthy Controls Clinical Trial Eligibility Overview. Trial Name: NCT04157179 — N/A
Sickle Cell Disease Research Study Groups: Healthy Controls, Extracorporeal Membrane Oxygenation survivors, Sickle Cell Anemia participants
Sickle Cell Disease Clinical Trial 2023: Healthy Controls Highlights & Side Effects. Trial Name: NCT04157179 — N/A
Healthy Controls 2023 Treatment Timeline for Medical Study. Trial Name: NCT04157179 — N/A
~126 spots leftby Dec 2027
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