Protocol Details
Exploring Near Infrared Spectroscopy (NIRS) Technologies for Assessment of Muscle Physiology, Tissue Oxygenation, and Blood Flow in Patients with Sickle Cell Disease (SCD)
This study is NOT currently recruiting participants.
Summary
Number |
000844-H |
Sponsoring Institute |
National Heart, Lung and Blood Institute (NHLBI) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 100 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Keywords |
Hemodynamic;
Six-Minute Walk Test |
Recruitment Keyword(s) |
None |
Condition(s) |
SCD |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Diagnostic Test: Non-Invasive Infrared Spectroscopy
|
Supporting Site |
National Heart, Lung, and Blood Institute |
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.
Eligibility
INCLUSION CRITERIA:
Sickle Cell Disease
-Individuals with confirmed sickle cell disease (HbSS and S beta 0 genotypes)
-18 years of age and older
-Willingness and capacity to provide informed consent
-Individuals must be on stable does of Hydroxyurea for 90 days prior to baseline visit
Ethnically matched controls
-Individuals with HbAA genotype
-18 years of age and older
-Willingness and capacity to provide informed consent
EXCLUSION CRITERIA:
Sickle Cell Disease
-Pain crisis requiring parenteral treatment within 4 weeks of screening/enrollment
-Blood transfusion within 60 days or exchange transfusion within 90 days of screening/enrollment
-Use of Oxbryta (voxelotor), Adakveo (crizanlizumab), and/or Endari (L-glutamine) within the 12 weeks prior to signing consent
-Women who are currently pregnant
-Presence of an arterial-venous shunt, recent axillary node dissection, or any deformity or surgical history that interferes with proper access for brachial cuff occlusion procedure of the extremities
-Mobility difficulties causing the inability to complete 6-minute walk test
Ethnically matched controls
-Women who are currently pregnant
-Presence of an arterial-venous shunt, recent axillary node dissection, or any deformity or surgical history that interferes with proper access for brachial cuff occlusion procedure of the extremities
-Mobility difficulties causing the inability to complete 6-minute walk test
-Blood transfusion within 60 days or exchange transfusion within 90 days of screening/enrollment
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT05604547