Sickle Cell DiseaseNCT01566890
Microvascular Blood Flow in Sickle Cell Anemia
A study testing regadenoson infusion with contrast-enhanced ultrasound and contrast-enhanced ultrasound in people with Sickle Cell Disease and Sickle Cell Anemia, run by Versiti Blood Health at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease, Sickle Cell Anemia
- What is being tested?
- regadenoson infusion with contrast-enhanced ultrasound and contrast-enhanced ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to 16 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 54Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Illinois
Chicago, Illinois, 60607
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Effect of Adenosine 2A Receptor Agonist Regadenoson on 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 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.
Read the detailed description
Sickle cell disease is an inherited blood disorder that affects one of every 400 African-Americans newborns in the United States. Sickle cell disease causes the red blood cells to change their shape from a round shape to a half-moon sickle shape. Individuals who have sickle cell disease have a different type of protein that carries oxygen in the blood (hemoglobin) than individuals without sickle cell disease. This different type of hemoglobin makes the red blood cell change into a crescent shape under certain conditions. Sickle shaped cells are a problem because the often get stuck on blood vessels blocking the flow of blood, and cause inflammation and injury to important areas of the body. These symptoms can lead to a painful occurrence called a "sickle cell crisis". Many individuals have to be admitted into the hospital because of the pain caused by a sickle cell crisis.
Regadenoson is a drug that may help prevent inflammation and injury caused by the sickle shaped cells. This drug is approved by the FDA to be used as a bolus during a heart stress test in people unable to exercise enough to put stress on the heart by making it beat faster. In a recent Phase I study, a safe dose for regadenoson was determined for adults with sickle cell disease. This dose was given by a slow IV infusion for a 24-48 hour period.
Hydroxyurea is the only FDA approved drug for the treatment of sickle cell disease. Hydroxyurea is a pill taken orally and works well but is not useful during a severe sickle cell crisis.
In this study researchers will use a new method, contrast-enhanced ultrasound (CEU), to visualize tiny blood vessels in cardiac and skeletal muscle. Changes in CEU measurements before, during and after administration of regadenoson will be examined. Contrast-enhanced ultrasounds will also be performed in individuals who are not having a sickle cell crisis. Some of those individuals will also undergo CEU while they are having a sickle cell crisis to compare those measurements . Lastly CEU results will be compared between individuals with sickle cell anemia and healthy African-Americans. These CEU's will be used to determine if there are changes in the blood flow of tiny blood vessels in certain conditions.
This study wants to know if this new method of contrast-enhanced ultrasound will be a useful tool for physicians to use in individuals with sickle cell anemia. The researchers also want to determine if this new method of CEU can be used to reveal if some treatments for sickle cell anemia work better than others.
- Conditions
- Sickle Cell Disease, Sickle Cell Anemia
- Being tested
- regadenoson infusion with contrast-enhanced ultrasound, contrast-enhanced ultrasound
- Keywords
- 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
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regadenoson infusion with contrast-enhanced ultrasoundDrug
Also called Lexiscan, regadenoson
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 or surgery
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 or surgery
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 or surgery
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 or surgery
Contrast-enhanced ultrasound will be performed on healthy volunteers (Technique Optimization Controls)
| Study group | Role | What they receive |
|---|---|---|
| Regadenoson ARM | Experimental | Adult subjects with sickle cell anemia will receive a regadenoson infusion with contrast-enhanced ultrasound Receives: Drug: regadenoson infusion with contrast-enhanced ultrasound |
| Sickle Cell Controls ARM | Other | Adult subjects with sickle cell anemia will receive contrast-enhanced ultrasound Receives: Procedure: contrast-enhanced ultrasound |
| Sickle Cell CEU ARM | Other | Adults subjects with sickle cell anemia will receive contrast-enhanced ultrasound Receives: Procedure: contrast-enhanced ultrasound |
| Healthy Control ARM | Other | Healthy African American control subjects without sickle cell anemia will receive contrast-enhanced ultrasound Receives: Procedure: contrast-enhanced ultrasound |
| Technique Optimization Controls | Other | Healthy volunteers will undergo contrast-enhanced ultrasound. Receives: Procedure: contrast-enhanced ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular Blood Flow Rate Change
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 the flow rate decreased at 24 hours.
Measured: Between baseline and 24 hours
Secondary outcomes (2)
MVBF Ratio of Change During a Pain Crisis
We planned to examine differences in microvascular blood flow using contrast-enhanced ultrasound (CEU) in adults with sickle cell anemia age 18 and older at baseline state compared to a pain crisis. We were measuring changes in microvascular blood flow in subjects with sickle cell anemia during a pain crisis by examining differences in microvascular blood flow using contrast-enhanced ultrasound at a baseline state, and comparing those measurements to contrast-enhanced ultrasound measurements during a pain crisis. A change ratio of >1 means that the flow rate increased during a pain crisis and a change ratio of <1 means that the flow rate decreased during a pain crisis.
Measured: Between baseline and between 7-30 days after pain crisis, if feasible
Microvascular Blood Flow in Sickle Cell Anemia Subjects Versus Control Subjects
Examine microvascular blood flow using contrast-enhanced ultrasounds in adult subjects with sickle cell anemia compared to microvascular blood flow of healthy African-American adults
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startJul 2012
- Primary completion5 Jul 2019
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versiti Blood Health
- Sponsor type
- University, hospital or other
- Collaborators
- Medical College of Wisconsin, La Jolla Institute for Allergy & Immunology, University of Illinois Chicago, Oregon Health and Science University, Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Joshua Field, Versiti Blood Health
- Investigators
- Joshua J Field, MD, MS, Principal investigator, Medical College of WisconsinJonathon Lindner, MD, Principal investigator, Oregon Health and Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566890
- Sponsor's protocol ID
- DD2011101
- Status last verified
- Jun 2024
- First submitted
- 28 Mar 2012
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ashley-Koch A, Yang Q, Olney RS. Sickle hemoglobin (HbS) allele and sickle cell disease: a HuGE review. Am J Epidemiol. 2000 May 1;151(9):839-45. doi: 10.1093/oxfordjournals.aje.a010288.
PubMed 10791557Charache S, Terrin ML, Moore RD, Dover GJ, Barton FB, Eckert SV, McMahon RP, Bonds DR. Effect of hydroxyurea on the frequency of painful crises in sickle cell anemia. Investigators of the Multicenter Study of Hydroxyurea in Sickle Cell Anemia. N Engl J Med. 1995 May 18;332(20):1317-22. doi: 10.1056/NEJM199505183322001.
PubMed 7715639{Field, 2011 #10443}Field, J. J., D. G. Nathan, et al. (2011).
Belcik JT, Davidson BP, Xie A, Wu MD, Yadava M, Qi Y, Liang S, Chon CR, Ammi AY, Field J, Harmann L, Chilian WM, Linden J, Lindner JR. Augmentation of Muscle Blood Flow by Ultrasound Cavitation Is Mediated by ATP and Purinergic Signaling. Circulation. 2017 Mar 28;135(13):1240-1252. doi: 10.1161/CIRCULATIONAHA.116.024826. Epub 2017 Feb 7.
PubMed 28174191
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adenosine 2A Receptor Agonist Regadenoson on Microvascular Blood Flow in Sickle Cell Anemia
- ClinicalTrials.gov ID
- NCT01566890
- Acronym / sponsor ID
- DD2011101
- Conditions
- Sickle Cell Disease, Sickle Cell Anemia
- Keywords
- sickle cell, sickle cell crisis, sickle cell pain crisis, vaso-occlusive crisis, vaso-occlusion, sickle cell anemia, sickle cell disease, genetic diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Versiti Blood HealthUniversity, hospital or other
- Collaborators
- Medical College of Wisconsin, La Jolla Institute for Allergy & Immunology, University of Illinois Chicago, Oregon Health and Science University, Dana-Farber Cancer Institute
- Study start
- Jul 2012
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Posted 26 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sickle cell disease is an inherited blood disorder that affects one of every 400 African-Americans newborns in the United States. Sickle cell disease causes the red blood cells to change their shape from a round shape to a half-moon sickle shape. Individuals who have sickle cell disease have a different type of protein that carries oxygen in the blood (hemoglobin) than individuals without sickle cell disease. This different type of hemoglobin makes the red blood cell change into a crescent shape under certain conditions. Sickle shaped cells are a problem because the often get stuck on blood vessels blocking the flow of blood, and cause inflammation and injury to important areas of the body. These symptoms can lead to a painful occurrence called a "sickle cell crisis". Many individuals have to be admitted into the hospital because of the pain caused by a sickle cell crisis.
Regadenoson is a drug that may help prevent inflammation and injury caused by the sickle shaped cells. This drug is approved by the FDA to be used as a bolus during a heart stress test in people unable to exercise enough to put stress on the heart by making it beat faster. In a recent Phase I study, a safe dose for regadenoson was determined for adults with sickle cell disease. This dose was given by a slow IV infusion for a 24-48 hour period.
Hydroxyurea is the only FDA approved drug for the treatment of sickle cell disease. Hydroxyurea is a pill taken orally and works well but is not useful during a severe sickle cell crisis.
In this study researchers will use a new method, contrast-enhanced ultrasound (CEU), to visualize tiny blood vessels in cardiac and skeletal muscle. Changes in CEU measurements before, during and after administration of regadenoson will be examined. Contrast-enhanced ultrasounds will also be performed in individuals who are not having a sickle cell crisis. Some of those individuals will also undergo CEU while they are having a sickle cell crisis to compare those measurements . Lastly CEU results will be compared between individuals with sickle cell anemia and healthy African-Americans. These CEU's will be used to determine if there are changes in the blood flow of tiny blood vessels in certain conditions.
This study wants to know if this new method of contrast-enhanced ultrasound will be a useful tool for physicians to use in individuals with sickle cell anemia. The researchers also want to determine if this new method of CEU can be used to reveal if some treatments for sickle cell anemia work better than others.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Regadenoson ARM | Experimental | Drug: regadenoson infusion with contrast-enhanced ultrasoundAdult subjects with sickle cell anemia will receive a regadenoson infusion with contrast-enhanced ultrasound |
| Sickle Cell Controls ARM | Other | Procedure: contrast-enhanced ultrasoundAdult subjects with sickle cell anemia will receive contrast-enhanced ultrasound |
| Sickle Cell CEU ARM | Other | Procedure: contrast-enhanced ultrasoundAdults subjects with sickle cell anemia will receive contrast-enhanced ultrasound |
| Healthy Control ARM | Other | Procedure: contrast-enhanced ultrasoundHealthy African American control subjects without sickle cell anemia will receive contrast-enhanced ultrasound |
| Technique Optimization Controls | Other | Procedure: contrast-enhanced ultrasoundHealthy volunteers will undergo contrast-enhanced ultrasound. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
- Diagnosis of sickle cell anemia confirmed by hemoglobin analysis
Key exclusion criteria (54 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regadenoson infusion with contrast-enhanced ultrasoundAlso: Lexiscan, regadenosonSubjects 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 | Drug | Regadenoson ARM |
| contrast-enhanced ultrasoundSubjects 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. | Procedure or surgery | Sickle Cell Controls ARM |
| contrast-enhanced ultrasoundContrast-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 | Procedure or surgery | Sickle Cell CEU ARM |
| contrast-enhanced ultrasoundContrast-enhanced ultrasound will be performed on healthy control subjects at baseline, on the first day of the study and 30 days later | Procedure or surgery | Healthy Control ARM |
| contrast-enhanced ultrasoundContrast-enhanced ultrasound will be performed on healthy volunteers (Technique Optimization Controls) | Procedure or surgery | Technique Optimization Controls |
Primary outcome
Microvascular Blood Flow Rate Change
Time frame: Between baseline and 24 hours
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 the flow rate decreased at 24 hours.
2 secondary outcomes
MVBF Ratio of Change During a Pain Crisis
Time frame: Between baseline and between 7-30 days after pain crisis, if feasible
Microvascular Blood Flow in Sickle Cell Anemia Subjects Versus Control Subjects
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10791557Ashley-Koch A, Yang Q, Olney RS. Sickle hemoglobin (HbS) allele and sickle cell disease: a HuGE review. Am J Epidemiol. 2000 May 1;151(9):839-45. doi: 10.1093/oxfordjournals.aje.a010288.
- Background: PubMed 7715639Charache S, Terrin ML, Moore RD, Dover GJ, Barton FB, Eckert SV, McMahon RP, Bonds DR. Effect of hydroxyurea on the frequency of painful crises in sickle cell anemia. Investigators of the Multicenter Study of Hydroxyurea in Sickle Cell Anemia. N Engl J Med. 1995 May 18;332(20):1317-22. doi: 10.1056/NEJM199505183322001.
- Background{Field, 2011 #10443}Field, J. J., D. G. Nathan, et al. (2011).
- Derived from this study: PubMed 28174191Belcik JT, Davidson BP, Xie A, Wu MD, Yadava M, Qi Y, Liang S, Chon CR, Ammi AY, Field J, Harmann L, Chilian WM, Linden J, Lindner JR. Augmentation of Muscle Blood Flow by Ultrasound Cavitation Is Mediated by ATP and Purinergic Signaling. Circulation. 2017 Mar 28;135(13):1240-1252. doi: 10.1161/CIRCULATIONAHA.116.024826. Epub 2017 Feb 7.
Related trials for Sickle Cell Disease
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
Active, not recruitingObservational study
Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease
Sickle Cell Anemia, Sickle Cell Thalassemia
Enrolling by invitationPhase 4
A Study to Provide Access to Mitapivat for Participants Who Previously Participated in an Agios-Sponsored Mitapivat Study
Pyruvate Kinase Deficiency, Anemia, Hemolytic
Active, not recruitingPhase 2
A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)
Sickle Cell Disease
RecruitingPhase 3
A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)
Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua J Field, MD, MS principal investigator
Medical College of Wisconsin
Jonathon Lindner, MD principal investigator
Oregon Health and Sciences University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regadenoson infusion with contrast-enhanced ultrasound and contrast-enhanced ultrasound in people with Sickle Cell Disease and Sickle Cell Anemia, run by Versiti Blood Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular Blood Flow Rate Change (time frame: Between baseline and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01566890, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.