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NCT01566890 · ClinicalTrials.gov registry record · NA
Microvascular Blood Flow in Sickle Cell Anemia
A NA study of Sickle Cell Disease and Sickle Cell Anemia, sponsored by Versiti Blood Health.
- Completed
- Registry status
- NA
- Development phase
- 91
- Enrollment target
- 2
- Study locations
NCT01566890: Completed NA study of Sickle Cell Disease and Sickle Cell Anemia, sponsored by Versiti Blood Health.
NCT01566890 is a NA study of Sickle Cell Disease and Sickle Cell Anemia that has completed, run by Versiti Blood Health. The registered enrollment target is 91 participants, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01566890, a NA study of Sickle Cell Disease and Sickle Cell Anemia, has completed, sponsored by Versiti Blood Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 91 participants
- Enrollment target
- 2
- Study locations
Study Summary
Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to change their shape from a round shape to a half-moon/crescent or sickled shape. Sickle-shaped cells can cause problems by getting stuck in blood vessels, blocking blood flow, and can cause inflammation and injury to important body parts. There are no specific treatments that improve this condition and promote blood flow hindered by sickle cell blockages. Another big challenge in managing sickle cell disease is that there are no good measures to determine changes and improvements in blood flow. Contrast-enhanced ultrasound is a technique currently used to detect blood flow in the heart, muscles, and other organs. It is extremely sensitive and can detect blood flow in the smallest of blood vessels. It would be very useful in helping healthcare providers know whether treatment strategies are improving blood flow during sickle cell blockages. The hypothesis is that contrast-enhanced ultrasound will be a feasible tool for determining changes in blood flow of subjects with sickle cell disease.
Primary Outcome
Primary outcome measure will be a 40% increase in skeletal muscle microvascular blood flow when 24 hour measurements are compared to baseline in subjects receiving Regadenoson. We took measurements in patients who received Regadenoson, as well as Sickle Cell controls. Both arms had microvascular blood flow (volume x velocity) measured at baseline and 24-hours, and those values were compared. A change ratio of \>1 means that the flow rate increased at 24 hours and a change ratio of \<1 means that
Conditions Studied
Interventions
- DRUG regadenoson infusion with contrast-enhanced ultrasound
- PROCEDURE contrast-enhanced ultrasound
Study Locations (2)
Illinois
- The University of Illinois - Chicago
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2012-07 |
| Est. Completion | 2020-11-16 |
| Phase | NA |
What the finished NCT01566890 record still lists
NCT01566890 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (69% lower).
The record links to 2 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which regadenoson infusion with contrast-enhanced ultrasound is the first listed.
NCT01566890 reports a single indexed study location in Illinois, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01566890 about?
NCT01566890 is a clinical study titled "Microvascular Blood Flow in Sickle Cell Anemia". Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to change their shape from a round shape to a half-moon/crescent or sickled shape. Sickle-shaped cells can cause problems by getting stuck in blood vessels, blocking blood flow, and can cause inflammation and in...
What is the current status of trial NCT01566890?
This trial is currently completed. It is a NA study. The enrollment target is 91 participants. The study started on 2012-07. Estimated completion is 2020-11-16.
What conditions does trial NCT01566890 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Sickle Cell Anemia.
What interventions are being tested in trial NCT01566890?
The interventions under investigation include: regadenoson infusion with contrast-enhanced ultrasound (DRUG), contrast-enhanced ultrasound (PROCEDURE).
Who is sponsoring clinical trial NCT01566890?
This trial is sponsored by Versiti Blood Health, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01566890 being conducted?
This trial has 2 study locations across Illinois, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01566890's enrollment target sits among peer trials
91 70th of 213 higher than 144 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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