Microvascular Blood Flow in Sickle Cell Anemia

This is an interventional diagnostic trial for Sickle Cell Disease focused on measuring sickle cell, sickle cell crisis, sickle cell pain crisis, vaso-occlusive crisis, vaso-occlusion, sickle cell anemia, sickle cell disease, genetic diseases, adenosine 2A Receptor Agonists, Lexiscan, Regadenoson, contrast-enhanced ultrasound, Hydroxyurea Read More

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 Criteria:

Regadenoson ARM Exclusion Criteria

• Hospitalization, emergency department visit or self-reported crisis within last 2 weeks for any reason or 4 weeks from acute chest syndrome
• Current physician diagnosis of active asthma (within last 12 months) or current use of 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-hypertensive medications
• Receiving chronic anti-coagulation or anti-platelet therapy
• History of metastatic cancer
• Receiving other investigational study agents, or have received a study agent in the last 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 2 weeks 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 within the 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-hypertensive medications
• 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-hypertensive medications
• 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