Cerebrovascular Reactivity Measurements With High-Density Diffuse Optical Tomography (HDDOT CVR)
The purpose of the study protocol is to identify imaging biomarkers for brain tissue under high metabolic stress at risk for permanent injury. We will measure oxygen extraction fraction (OEF) and cerebrovascular reactivity (CVR) in participants with and without perturbations in cerebral oxygen delivery over time to determine each parameter's role in clinical and radiologic neurologic outcomes. Measuring OEF can be done with specialized MRI sequences. Measuring CVR requires a vasoactive response, such as carbon dioxide. In order to deliver 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. We will also use a high density diffuse optical tomography (HD-DOT) cap to assess the measurement of OEF and CVR. This study will investigate both regional OEF and CVR simultaneously to understand each marker's unique developmental trajectory and contribution to stroke risk in children. This work will expand insights into mechanisms of stroke in children and assess the feasibility of the HD-DOT cap for obtaining these insights by comparing a cohort of optical CVR and a cohort of MRI CVR.
In addition to the MRI and/or HD-DOT cap with RespirAct, participants may also have their vitals measured, complete cognitive testing, and complete a blood draw with a study visit. Participants may be followed for up to three years and may complete both an MRI scan and an HD-DOT scan within 1 week-12 months of each other. Participants may be invited back to repeat MRI and/or HD-DOT scans 1-2 times over the next three years.
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kristin Guilliams, MD
- 電話番号：3144545436
- メール：kristinguilliams@wustl.edu
研究場所
-
-
Missouri
-
St Louis、Missouri、アメリカ、63110
- 募集
- Washington University in St. Louis
-
コンタクト：
- Kristin Guilliams, MD
- 電話番号：3144546120
- メール：kristinguilliams@wustl.edu
-
主任研究者：
- Kristin Guilliams, MD
-
主任研究者：
- Adam Eggebrecht
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 6-70 Years Old
- Able to participate in MRI scan without sedation
- May or may not have HbSS or beta thalassemia null genotypes of sickle cell anemia
Exclusion Criteria:
- Significant craniofacial malformation or technical contraindications to DOT monitoring (for HDDOT imaging)
- Metal in/on the body that is contraindicated for MRI safety (for MRI imaging)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：健康管理
|
Participants inhale carbon dioxide, delivered by computer-controlled delivery system, to target specific levels of carbon dioxide while in magnetic resonance imaging scan and/or during HDDOT imaging to measure cerebrovascular reactivity.
|
|
アクティブコンパレータ：Sickle Cell Anemia Participants
|
Participants inhale carbon dioxide, delivered by computer-controlled delivery system, to target specific levels of carbon dioxide while in magnetic resonance imaging scan and/or during HDDOT imaging to measure cerebrovascular reactivity.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
HDDOT-Based Cerebrovascular Reactivity
時間枠：~15 minutes during the MRI scan and ~60 minutes during the HDDOT imaging.
|
Changes in relative concentration of deoxyhemoglobin with fluctuations of carbon dioxide as compared to gold standard measurement of MRI-based cerebrovascular reactivity.
|
~15 minutes during the MRI scan and ~60 minutes during the HDDOT imaging.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cerebral Oxygen Metabolism
時間枠：From administration of carbon dioxide to end of inhalation of carbon dioxide -- 60 minutes during MRI and/or HDDOT imaging.
|
MRI-based cerebral based blood flow oxygen extraction fraction will be combined with laboratory data estimating arterial oxygen content to calculate cerebral oxygen metabolism.
|
From administration of carbon dioxide to end of inhalation of carbon dioxide -- 60 minutes during MRI and/or HDDOT imaging.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 202508036
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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