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Carbon Dioxide for Stroke in Children (COMIC Trial)

Q: Is it possible for me to join this experiment?

<p>This trial seeks out 350 patients affected by <a href="https://www.withpower.com/clinical-trials/stroke">stroke</a>, ranging from 3 years old to 50. Participants must have a clean <a href="https://www.withpower.com/clinical-trials/mental-health">mental health</a> record and be healthy enough for an <a href="https://www.withpower.com/clinical-trials/mri">MRI</a> scan without sedation; they can suffer occasional headaches if not taking preventative medicine. Additionally, those enrolling cannot have ever had <a href="https://www.withpower.com/clinical-trials/epilepsy">epilepsy</a> or cerebrovascular disease, nor should they be on vasodilatory medications such as sildenafil or verapamil. Lastly, <a href="https://www.withpower.com/clinical-trials/all">all</a> applicants are required to possess either the Hb SS form of thalassemia or SBeta-thal genotype.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the beginning of the mri scan to the completion of the mri scan -- 75 minutes.

Awards & highlights

COMIC Trial 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.Check my eligibility

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.See study design

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.

COMIC Trial 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.

Select...

I am between 3 and 50 years old.

Select...

I can undergo an MRI scan without needing to be sedated.

COMIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the beginning of the mri scan to the completion of the mri scan -- 75 minutes.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the beginning of the mri scan to the completion of the mri scan -- 75 minutes.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the beginning of the mri scan to the completion of the mri scan -- 75 minutes. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cerebral Oxygen Metabolism

Secondary outcome measures

Cerebrovascular Reactivity

COMIC 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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,457 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment enrolling individuals over 40 years of age?

"The minimum age requirement for this clinical trial is 3 years, while the upper limit of participants' ages cannot exceed 50."

Answered by AI

Is it possible for me to join this experiment?

"This trial seeks out 350 patients affected by stroke, ranging from 3 years old to 50. Participants must have a clean mental health record and be healthy enough for an MRI scan without sedation; they can suffer occasional headaches if not taking preventative medicine. Additionally, those enrolling cannot have ever had epilepsy or cerebrovascular disease, nor should they be on vasodilatory medications such as sildenafil or verapamil. Lastly, all applicants are required to possess either the Hb SS form of thalassemia or SBeta-thal genotype."

Answered by AI

To what extent is the current clinical trial taking on participants?

"Affirmative. Clinicaltrials.gov's repository of data confirms that this research, which was first listed on October 17th 2019, is actively recruiting participants. 350 people need to be selected from a single clinical site."

Answered by AI

Are there any available positions in this research endeavor for participants?

"According to clinicaltrials.gov, this medical trial is currently seeking patients for participation. This study was initially launched on October 17th 2019 and most recently edited on November 8 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cerebral Oxygen Metabolism in Children

2019. "Cerebral Oxygen Metabolism in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04157179.

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