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:
– To quantify baseline hemodynamics in SCD subjects at steady state utilizing NIRS and compare against established clinical/biomarker outcomes, including the six-minute walk test, transthoracic echocardiogram and pro BNP levels.
Secondary Objective: To compare NIRS measurements in SCD subjects at steady state with NIRS measurements in healthy controls.
Tertiary Objective:
– To quantify baseline hemodynamics in ethnically-matched healthy control subjects (HbAA) utilizing NIRS and compare against established clinical/biomarker outcomes, including the six-min
Endpoints: Primary Endpoints:
NIRS measurements that characterize tissue composition, tissue metabolism, and blood flow will be collected in SCD subjects in steady state. Primary endpoints include:
Oxy-/deoxy- hemoglobin concentration for assessing tissue composition
Tissue oxygen saturation for assessing tissue metabolism
Blood flow index: Post-occlusion hyperemic response for describing endothelial function.
We will examine correlations between these endpoints and biomarker and clinical endpoints among SCD participants to assess the extent to which NIRS measurements may capture clinical features of SCD.
Secondary Endpoints:
The same endpoints described above will be collected from healthy controls and used to assess differences in tissue composition, tissue metabolism, blood flow between SCD subjects and controls.
Tertiary Endpoints:
To evaluate the tertiary objective of characterizing NIRS responses in healthy controls we will collect:
Oxy-/deoxy- hemoglobin concentration for assessing tissue composition
Tissue oxygen saturation for assessing tissue metabolism
Blood flow index: Post-occlusion hyperemic response for describing endothelial function.
Source: View full study details on ClinicalTrials.gov
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