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治験 NCT06150989 (BLOOM)（対象：心血管疾患、心疾患の危険因子）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Black Women's Life Experience On Cardiovascular Health Via Ongoing Monitoring (BLOOM)
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06150989 (BLOOM) は 観察研究 臨床試験 で、心血管疾患、心疾患の危険因子 に関するものです。現在は 募集中 で、2024年3月4日 から開始しています。80 名の参加者 の募集が計画されています。この治験は The University of Texas at Arlington によって主催され、2026年3月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年4月29日 です。
概要
This pilot study uses a state-of-the-science combination of remote behavioral monitoring, real-time experience sampling, in-lab physiological assessments, and extraction of neighborhood-level characteristics to (1) Examine the impact of daily experience (i.e., racial discrimination, affective states, stress) on health behaviors (i.e., physical activity, sedentary behavior, sleep) at the intrapersonal level among Black women; (2) Test the association between daily behaviors and impairments in biomarkers associated with vascular function/health (i.e., augmented systemic inflammation and oxidative stress, impaired peripheral/cerebral vascular function, increased large artery stiffness), as well as the impact of daily experience on the relationship between behaviors and vascular function; and (3) Explore the influence of neighborhood-level characteristics (i.e., social environment factors: i.e., neighborhood income and poverty, racial composition; and built environment context, such as park density and walkability) on daily experience and health behaviors.
公式タイトル
A Biobehavioral Approach to Understand the Multilevel Determinants of Cardiovascular Health in Black Women
疾患／病気
心血管疾患心疾患の危険因子刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- BLOOM
- 2023-0344
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Observational Group Black women enrolled in this study will complete a series of lab-based assessments that evaluate their vascular health, followed by a 10-day free-living monitoring period with mobile and wearable devices. | 観察グループ All participants will go through a series of lab-based assessments to evaluate their vascular health. These assessments include: heart rhythm/rate, blood pressure, large blood vessel flow, central aortic blood pressure and pulse wave velocity, brain blood flow, carbon dioxide concentration, flow mediated dilation/blood vessel responsiveness, breathing rate, and cerebral vasomotor reactivity. In addition, venous blood sample will be taken to identify biomarkers that are associated with elevating blood pressure and decreasing blood flow.
The 10-day monitoring period includes a wrist-worn activity tracker and a blood pressure monitor bracelet; a smartphone app that will prompt surveys up to 6 times a day to assess behaviors, social/physical context, mood/stress, and experience of racial discrimination/microaggression. Participants will also collect saliva samples on three consecutive days during the 10-day monitoring period. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Macrovascular function | Macrovascular function will be assessed as brachial artery vasodilation following a period of suprasystolic cuff occlusion. Microvascular function will be assessed as the % change in blood velocity from baseline following cuff release. | Day 1 |
Arterial Stiffness | An appropriately sized blood pressure cuff will be placed on the upper arm and central (aortic) and peripheral (arm) blood pressure will be assessed using the non-invasive SphygmoCor Xcel device. This device provides measurement of augmentation index (in percentage), which is an indicator of arterial stiffness. | Day 1 |
Blood Flow Measurements (Large Blood Vessels) | A Doppler ultrasound probe will be used to measure blood flow in the upper arm, leg, and/or neck (e.g., brachial artery, femoral artery, and carotid artery, respectively). | Day 1 |
Blood Flow Measurements (Cerebral Blood Vessels) | Cerebral blood flow will be indexed from the velocity of blood flowing through the middle cerebral artery. This will be accomplished using transcranial Doppler ultrasound. | Day 1 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Physical activity | Daily physical activity level will be assessed via a wrist-worn accelerometer. | Day 2 to Day 11 |
適格基準
対象年齢
成人
試験の最低年齢
18 Years
対象性別
女性
健康なボランティアを受け入れる
はい
- born and identified as female;
- between 18-49 years old;
- self-identify as Black or African American;
- not currently pregnant;
- ownership of a smartphone with Internet access;
- able to speak and read English
- diagnosed hypertension, cardiovascular, respiratory, metabolic, and/or neurological disorders;
- functional limitations or health issues that preclude physical activity;
- currently taking medications for thyroid function or psychological conditions such as depression, anxiety, and mood disorders;
- current use of oral or inhalant corticosteroids for asthma;
- have regularly smoked within the last 2 years.
The University of Texas at ArlingtonAmerican Heart Association責任者
Yue Liao, 研究責任者, Assistant Professor, The University of Texas at Arlington
連絡先情報がありません。
1 1カ国の場所
Texas
The University of Texas at Arlington, Arlington, Texas, 76010, United States
Physical Activity and Wearable Sensors Lab, 連絡先, 8172728524, [email protected]
Yue Liao, PhD, MPH, 研究責任者
募集中