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NCT05604547 · ClinicalTrials.gov registry record
Exploring Near Infrared Spectroscopy (NIRS) Technologies for Assessment of Muscle Physiology, Tissue Oxygenation, and Blood Flow in Patients With Sickle Cell Disease (SCD)
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 49
- Enrollment target
NCT05604547: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT05604547 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 49 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05604547 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 49 participants
- Enrollment target
Study Summary
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....
Primary Outcome
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
Interventions
- DIAGNOSTIC_TEST Non-Invasive Infrared Spectroscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2022-11-28 |
| Est. Completion | 2025-01-24 |
What the finished NCT05604547 record still lists
NCT05604547 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 49 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Non-Invasive Infrared Spectroscopy is the first listed.
NCT05604547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05604547 about?
NCT05604547 is a clinical study titled "Exploring Near Infrared Spectroscopy (NIRS) Technologies for Assessment of Muscle Physiology, Tissue Oxygenation, and Blood Flow in Patients With Sickle Cell Disease (SCD)". 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 calle...
What is the current status of trial NCT05604547?
This trial is currently completed. The enrollment target is 49 participants. The study started on 2022-11-28. Estimated completion is 2025-01-24.
What interventions are being tested in trial NCT05604547?
The interventions under investigation include: Non-Invasive Infrared Spectroscopy (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05604547?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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