CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 91 enrolled
Drug / intervention
regadenoson infusion with contrast-enhanced ultrasound +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01566890
NCT01566890N/ACompleted

Effect of Adenosine 2A Receptor Agonist Regadenoson on Microvascular Blood Flow in Sickle Cell Anemia

Versiti Blood Health·interventional·Posted Mar 29, 2012·Updated Jun 26, 2024

In Brief

A clinical study evaluating regadenoson infusion with contrast-enhanced ultrasound and contrast-enhanced ultrasound for Sickle Cell Disease and Sickle Cell Anemia. Completed, enrolled 91 participants across 2 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2012
Enrollment StartJul 1, 2012
Primary CompletionJul 5, 2019
Study CompletionNov 16, 2020
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 14.3 years ago

Interventions

regadenoson infusion with contrast-enhanced ultrasounddrug

Subjects who are not having a pain crisis receive a 24-hour infusion of regadenoson. Contrast-enhanced ultrasound will be performed four times during the 24 hour regadenoson infusion

contrast-enhanced ultrasoundprocedure

Subjects who are not having a pain crisis will have contrast-enhanced ultrasound performed up to four times over a two-day period. Time points will resemble the time course used for the Regadenoson Arm, although no investigational drug will be given.

contrast-enhanced ultrasoundprocedure

Contrast-enhanced ultrasound will be performed on adults with sickle cell anemia at baseline who are not having a pain crisis and performed again during a pain crisis

contrast-enhanced ultrasoundprocedure

Contrast-enhanced ultrasound will be performed on healthy control subjects at baseline, on the first day of the study and 30 days later

contrast-enhanced ultrasoundprocedure

Contrast-enhanced ultrasound will be performed on healthy volunteers (Technique Optimization Controls)