Microvascular Blood Flow in Sickle Cell Anemia

• Status: Active, not recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Blood Center of Wisconsin; Versiti
• Collaborators: Dana-Farber Cancer Institute; La Jolla Institute for Allergy & Immunology; Medical College of Wisconsin; Oregon Health and Science University; University of Illinois at Chicago
• Treatments: Adenosine; Regadenoson

Criteria

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