Exploring Near Infrared Spectroscopy (NIRS) Technologies for Assessment of Muscle Physiology, Tissue Oxygenation, and Blood Flow in Patients With Sickle Cell Disease (SCD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- To quantify baseline hemodynamic function in SCD subjects at steady state utilizing NIRS in parallel with clinical assessments of cardiovascular function, including the 6-minute walk test (6MWT), pro BNP levels and transthoracic echocardiogram.
研究概览
简要总结
Sickle cell disease (SCD) is an inherited disorder of the blood. SCD can injure the smallest blood vessels, which can cause pain and damage organs all over the body. Some treatments are available, but researchers need better ways to monitor the effects of these treatments. An imaging technique called near infrared spectroscopy (NIRS) may be helpful.
Objective:
To test NIRS as a tool for measuring oxygen levels, blood flow, and the makeup of skin and muscle in patients with SCD.
Eligibility:
People aged 18 years and older with SCD. Healthy volunteers are also needed as a comparison for the changes in SCD patients.
Design:
Participants will be screened. They will have a physical exam, and 1 teaspoon of blood will be drawn.
Participants will have NIRS testing on their second visit. Probes will be placed on their skin. A blood pressure cuff will be placed on their arm. The cuff will be filled with air for up to 5 minutes and then released. Participants may be asked to breathe at a certain rate or hold their breath during these measurements.
At this visit, participants will also have an ultrasound exam to get images of their heart. They will be monitored while they walk for 6 minutes. They will have 1 tablespoon of blood drawn. Their height, weight, and vital signs will be measured.
Participants may be asked to return for up to 4 additional visits for NIRS testing within 120 days, but this is optional. The visits must be at least 3 days apart. Each visit will last up to an hour....
详细描述
Study Description:
This is a non-interventional protocol to explore the role of near infrared spectroscopy (NIRS) technologies as a monitoring tool for assessment of peripheral tissue dynamics in patients with sickle cell disease (SCD). The study will be performed in the outpatient setting. Ethnically-matched healthy subjects will be recruited to participate in baseline NIRS assessments and serve as controls. It is hypothesized that quantitative NIRS will be sensitive to differences in hemodynamic responses between SCD patients and healthy controls in the setting of endothelial dysfunction. In parallel, routine methods of assessing cardiovascular health, including the six-minute walk test, transthoracic echocardiography, and cardiac biomarkers such as pro BNP will be acquired. NIRS holds tremendous potential as a novel point of care test in patients with SCD and may provide further insight on the natural history of the disease and allow for individualized clinical management.
A subset of up to 10 participants in each cohort (SCD patients as well as healthy AA subjects) may be invited to return to the Clinical Center for clinical and NIRS reassessment periodically for a maximum of 4 additional visits, at least 3 days apart, within a 120- day period from their initial (baseline) visit to test repeatability of the NIRS measurements.
Objectives:
Primary Objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To quantify baseline hemodynamic function in SCD subjects at steady state utilizing NIRS in parallel with clinical assessments of cardiovascular function, including the 6-minute walk test (6MWT), pro BNP levels and transthoracic echocardiogram.
时间窗: 120 days
Baseline NIRS measurements will permit real time assessment of peripheral tissue hemodynamics, including oxygenation and blood flow, in relation to established markers of cardiovascular health in subjects with SCD, including the 6MWT, TTE, and pro BNP levels
次要结局
- To assess baseline tissue hemodynamic function utilizing NIRS in ethnically-matched healthy control subjects without (AA) and with sickle cell trait (AS) as compared to baseline NIRS assessments in patients with SCD.(120 days)