Phase
Condition
Sickle Cell Disease
Anemia
Red Blood Cell Disorders
Treatment
contrast-enhanced ultrasound
regadenoson infusion with contrast-enhanced ultrasound
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Regadenoson ARM Inclusion Criteria:
Diagnosis of sickle cell anemia confirmed by hemoglobin analysis
Ages 18 to 70 years
Subjects must have laboratory indices as outlined by the protocol
Reliable IV access as determined by physician
Sickle Cell Controls ARM Inclusion Criteria:
Diagnosis of sickle cell anemia confirmed by hemoglobin analysis
Ages 18 to 70 years
Sickle Cell CEU ARM Inclusion Criteria:
Diagnosis of sickle cell anemia, confirmed by hemoglobin analysis
Males and females age 18-70 years
Healthy Control ARM Inclusion Criteria:
African American
Ages 18 to 70 years
Technique Optimization Control ARM Inclusion Criteria:
-Ages 18 to 70 years
Exclusion
Exclusion Criteria:
Regadenoson ARM Exclusion Criteria
Hospitalization, emergency department visit or self-reported crisis within last 2weeks for any reason or 4 weeks from acute chest syndrome
Current physician diagnosis of active asthma (within last 12 months) or current useof asthma medications
Second or third degree AV block or sinus node dysfunction
Known or suspected right to left sided cardiac shunts
History of a bleeding diathesis
History of clinically overt stroke
History of severe hypertension not adequately controlled with anti-hypertensivemedications
Receiving chronic anti-coagulation or anti-platelet therapy
History of metastatic cancer
Receiving other investigational study agents, or have received a study agent in thelast 30 days
Uncontrolled intercurrent illness
Pregnant or breastfeeding women
Subjects who have a HIV infection
Subjects who have had a hematopoietic stem cell transplant
Subjects who are taking medications that may interact with the investigational agent
Prior hypersensitivity reactions to either regadenoson or ultrasound contrast agents
Sickle Cell Controls Exclusion Criteria:
Hospitalization, emergency department visit or self-reported crisis within last 2weeks for any reason or 4 weeks from acute chest syndrome
Known pregnancy
Known history of HIV
Known or suspected right to left sided cardiac shunts
Receiving other investigational study agents, or have received a study agent withinthe last 30 days
Subjects who have had a hematopoietic stem cell transplant
Prior hypersensitivity reactions to ultrasound contrast agents
History of severe hypertension not adequately controlled with anti-hypertensivemedications
Uncontrolled intercurrent illness
Sickle Cell CEU ARM Exclusion Criteria:
Pregnant women
Subjects who have a HIV infection
History of stem cell transplant
Current involvement in a therapeutic clinical trial
Known or suspected right to left sided cardiac shunts
Prior hypersensitivity reactions to ultrasound contrast agents
History of severe hypertension not adequately controlled with anti-hypertensivemedications
Uncontrolled intercurrent illness
Healthy Control ARM Exclusion Criteria:
Sickle cell disease or sickle cell trait
Known or suspected right to left sided cardiac shunts
Diagnosis of type 1 or type 2 diabetes mellitus
Hypertension
History or current diagnosis of dyslipidemia or taking lipid lowering drugs
Diagnosis of coronary artery disease or peripheral vascular disease
Body weight greater than 10% of ideal weight
Uncontrolled intercurrent illness
Pregnant or breastfeeding women
Subjects who have a HIV infection
Prior hypersensitivity reactions to ultrasound contrast agents
Technique Optimization Control ARM Exclusion Criteria:
Known sickle cell disease or sickle cell trait
Known or suspected right to left sided cardiac shunts
Uncontrolled intercurrent illness
Known pregnant or breastfeeding women
Prior hypersensitivity reactions to ultrasound contrast agents
Study Design
Study Description
Connect with a study center
The University of Illinois
Chicago, Illinois 60607
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.