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Non-Invasive Infrared Spectroscopy for Sickle Cell Disease
N/A
Recruiting
Led By Swee Lay Thein, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a tool to measure changes in oxygen levels, blood flow, and the makeup of skin and muscle in people aged 18+ with sickle cell disease. Healthy volunteers are also needed. Participants will have physical exams, tests, and blood draws.
Who is the study for?
This trial is for adults with Sickle Cell Disease (SCD), including those on stable Hydroxyurea treatment. Healthy individuals are also needed for comparison. Pregnant women, people who can't walk for 6 minutes due to mobility issues, recent users of certain SCD medications, and those with specific surgical histories or blood transfusions are excluded.
What is being tested?
Researchers are testing Near Infrared Spectroscopy (NIRS) as a non-invasive method to measure muscle oxygen levels, blood flow, and tissue composition in patients with SCD compared to healthy controls. The study involves physical exams, NIRS tests during various activities, and up to five visits.
What are the potential side effects?
Since the intervention involves non-invasive imaging technology without medication administration or invasive procedures, significant side effects aren't expected. However, discomfort from wearing probes or having a blood pressure cuff inflated might occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 120 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Echocardiography
Secondary study objectives
Hemodynamics
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Single-arm study
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,929 Previous Clinical Trials
47,765,180 Total Patients Enrolled
Swee Lay Thein, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
12 Previous Clinical Trials
7,875 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a blood transfusion in the last 60 days or an exchange transfusion in the last 90 days.I have been taking a consistent dose of Hydroxyurea for the last 90 days.I am willing and able to give my consent for treatment.I have had a blood transfusion within the last 60 days or an exchange transfusion within the last 90 days.I am 18 or older with an HbAA genotype.I cannot complete a 6-minute walk test due to mobility issues.I am 18 or older with confirmed sickle cell disease.I have had a sickle cell pain crisis needing injection treatment in the last 4 weeks.I have used Oxbryta, Adakveo, or Endari for my sickle cell disease in the last 12 weeks.I have sickle cell disease and can't complete a 6-minute walk due to mobility issues.I have a condition or past surgery that affects arm measurements.I have sickle cell disease and a condition that may affect blood flow measurement in my arms.I have sickle cell disease and am currently pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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