Sickle Cell DiseasePhase 2NCT05583721
Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET
A Phase 2 study testing [13N]NH3, Lexiscan and Positron emission tomography in people with Sickle Cell Disease, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
There is limited information on what causes injury to the heart in individuals with Sickle Cell Disease (SCD). Researchers in this study want to see if decreased blood flow to the heart during stress could be causing the heart damage seen in SCD patients. Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- [13N]NH3, Lexiscan and Positron emission tomography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2023to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 21 years of age
- Black
- Two or less abnormal diastolic parameters
Who cannot join
- Recent hospitalization for vaso-occlusive pain crisis or acute chest syndrome in last 4 weeks
- Blood transfusion in the last 3 months
- Individuals with signs, symptoms or EKG findings of acute myocardial ischemia, infarction or unstable angina
- Individuals with history of VT/VF or SVT
- Previous cardiac surgery
- Known congenital heart disease (other than patent ductus arteriosus or Atrial septal defect)
Show all 47Show fewer
- Stenotic valvular disease or left main coronary artery stenosis
- History of myo/pericarditis
- Left ventricle systolic dysfunction
- Cardiovascular instability/uncontrolled hypertension (h/o hypertensive urgency or emergency)
- History of sinus node dysfunction or high grade AV nodal block
- History of aborted sudden cardiac death or cardiac arrest
- Current seizure disorder on AED
- Pregnant/Breast-feeding
- Any medical or social reason, which, in the opinion of the principal investigators would make the participation of the subject ill-advised.
- Diagnosed with three or more abnormal diastolic parameters (based on guidelines by American Society of echocardiography)
- Recent hospitalization for vaso-occlusive pain crisis or acute chest syndrome in last 4 weeks
- Blood transfusion in the last 3 months
- Individuals with signs, symptoms or EKG findings of acute myocardial ischemia, infarction or unstable angina
- Individuals with history of VT/VF or SVT
- Previous cardiac surgery
- Known congenital heart disease (other than patent ductus arteriosus or Atrial septal defect)
- Stenotic valvular disease or left main coronary artery stenosis
- History of myo/pericarditis
- Left ventricle systolic dysfunction
- Cardiovascular instability/uncontrolled hypertension (h/o hypertensive urgency or emergency)
- History of sinus node dysfunction or high-grade AV nodal block
- History of aborted sudden cardiac death or cardiac arrest
- Current seizure disorder on AED
- Pregnant/Breast-feeding
- Any medical or social reason, which, in the opinion of the principal investigators would make the participation of the subject ill-advised.
- All genotypes of SCD
- Diagnosed with three or more abnormal diastolic parameters (based on guidelines by American Society of echocardiography)
- Anemia of grade 2 or worse (per CTCAE v5.0) at study visit 1
- Individuals with signs, symptoms or EKG findings of acute myocardial ischemia, infarction or unstable angina
- Individuals with history of VT/VF or SVT
- Previous cardiac surgery
- Known congenital heart disease (other than patent ductus arteriosus or Atrial septal defect)
- Stenotic valvular disease or left main coronary artery stenosis
- History of myo/pericarditis
- Left ventricle systolic dysfunction
- Cardiovascular instability/uncontrolled hypertension (h/o hypertensive urgency or emergency)
- History of sinus node dysfunction or high-grade AV nodal block
- History of aborted sudden cardiac death or cardiac arrest
- Current seizure disorder on AED
- Pregnant/Breast- feeding
- Any medical or social reason, which, in the opinion of the principal investigators would make the participation of the subject ill-advised.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Parul Rai, MD, 888-226-4343, referralinfo@stjude.org
Parul Rai, MD
About this study
Official title: An Evaluation of the Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET (Stress-Rest) Myocardial Perfusion Imaging (MYPERS)
There is limited information on what causes injury to the heart in individuals with Sickle Cell Disease (SCD). Researchers in this study want to see if decreased blood flow to the heart during stress could be causing the heart damage seen in SCD patients. They also want to test people who don't have SCD to see if their hearts react the same way under stress.
Primary Objective
Read more
- To estimate the coronary flow reserve (CFR) (also referred to as myocardial perfusion reserve), as measured by PET stress-rest myocardial perfusion imaging, in SCD patients with and without diastolic dysfunction, and healthy controls.
Secondary Objectives
- To investigate the relationship between decreased CFR (quantified with PET stress- rest myocardial perfusion imaging) and presence of abnormal diastolic parameters
Read the detailed description
This study requires two visits. The first visit includes blood tests, an electrocardiogram (EKG), and an echocardiogram. The second visit includes a positron emission tomography (PET) stress test and a blood test.
Subjects will be considered off-study one week after all post PET imaging study tests have been completed along with the next day and one-week follow-up phone calls are completed.
- Conditions
- Sickle Cell Disease
- Being tested
- [13N]NH3, Lexiscan, Positron emission tomography
- Keywords
- Sickle Cell Disease patients, Healthy controls, Abnormal diastolic heart function, Coronary Flow Reserve (CFR), Coronary microvasculature dysfunction, Myocardial perfusion reserve, Positron emission tomography (PET) imaging, PET (stress-rest) myocardial perfusion imaging
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[13N]NH3Drug
Also called [N-13] Ammonia, azane, CAS# 34819-78-8
Ammonia N 13 (a radioactive tracer) will be given per intravenous (IV) injection for diagnostic purposes in conjunction with positron emission tomography (PET) imaging.
LexiscanDrug
Also called Regadenoson
Given IV prior to PET stress test
Positron emission tomographyDiagnostic test
Also called PET
Participants will complete a onetime PET (stress-rest) myocardial perfusion scan.
| Study group | Role | What they receive |
|---|---|---|
| Stratum A | Experimental | Sickle Cell patients with diastolic dysfunction Receives: Drug: [13N]NH3; Drug: Lexiscan; Diagnostic Test: Positron emission tomography |
| Stratum B | Experimental | Sickle cell patients without diastolic dysfunction Receives: Drug: [13N]NH3; Drug: Lexiscan; Diagnostic Test: Positron emission tomography |
| Stratum C | Experimental | Healthy controls Receives: Drug: [13N]NH3; Drug: Lexiscan; Diagnostic Test: Positron emission tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and standard deviation of coronary flow reserve (CFR)
We will estimate the mean and standard deviation of CFR, as measured by PET myocardial blood flow reserve imaging, in young adult SCD patients with and without diastolic dysfunction and healthy controls.
Measured: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)
CFR difference among Stratum A, Stratum B, and Stratum C
We will compare whether the CFR is different among 3 predefined strata: Stratum A; SCD with diastolic dysfunction patients , Stratum B; SCD without dysfunction patient control, and Stratum C; normal healthy controls by one-way ANOVA or Kruskal-Wallis one-way analysis of variance, depending on the distribution of the data. If the difference exists, the pairwise comparison will be carried out by two sample t test or Wilcoxon rank sum test between two strata.
Measured: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)
Secondary outcomes (1)
Relationship between decreased CFR (quantified with PET stress-rest myocardial perfusion imaging) and presence of abnormal diastolic parameters
The following is the grouping of diastolic parameters used in this study: Group 1: 0 or any 1 diastolic variable abnormal; Group 2: Any 2 variables abnormal; Group 3: Any 3 or more variables abnormal . We will first summarize the mean and standard deviation CFR values for each diastolic group. One-way ANOVA or Kruskal-Wallis one-way ANOVA will be used to explore whether there are any statistically significant differences between the means of these three groups. If a difference exists, the pairwise comparison will be carried out by two sample t test or Wilcoxon rank sum test between two groups.
Measured: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start10 Oct 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parul Rai, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583721
- Sponsor's protocol ID
- MYPERS
- Status last verified
- May 2026
- First submitted
- 13 Oct 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET (Stress-Rest) Myocardial Perfusion Imaging (MYPERS)
- ClinicalTrials.gov ID
- NCT05583721
- Acronym / sponsor ID
- MYPERS
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease patients, Healthy controls, Abnormal diastolic heart function, Coronary Flow Reserve (CFR), Coronary microvasculature dysfunction, Myocardial perfusion reserve, Positron emission tomography (PET) imaging, PET (stress-rest) myocardial perfusion imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is limited information on what causes injury to the heart in individuals with Sickle Cell Disease (SCD). Researchers in this study want to see if decreased blood flow to the heart during stress could be causing the heart damage seen in SCD patients. They also want to test people who don't have SCD to see if their hearts react the same way under stress.
Primary Objective
- To estimate the coronary flow reserve (CFR) (also referred to as myocardial perfusion reserve), as measured by PET stress-rest myocardial perfusion imaging, in SCD patients with and without diastolic dysfunction, and healthy controls.
Secondary Objectives
- To investigate the relationship between decreased CFR (quantified with PET stress- rest myocardial perfusion imaging) and presence of abnormal diastolic parameters
Detailed description
This study requires two visits. The first visit includes blood tests, an electrocardiogram (EKG), and an echocardiogram. The second visit includes a positron emission tomography (PET) stress test and a blood test.
Subjects will be considered off-study one week after all post PET imaging study tests have been completed along with the next day and one-week follow-up phone calls are completed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stratum A | Experimental | Drug: [13N]NH3, Drug: Lexiscan, Diagnostic Test: Positron emission tomographySickle Cell patients with diastolic dysfunction |
| Stratum B | Experimental | Drug: [13N]NH3, Drug: Lexiscan, Diagnostic Test: Positron emission tomographySickle cell patients without diastolic dysfunction |
| Stratum C | Experimental | Drug: [13N]NH3, Drug: Lexiscan, Diagnostic Test: Positron emission tomographyHealthy controls |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 21 years of age
- Black
- Two or less abnormal diastolic parameters
Key exclusion criteria (47 listed)
- Recent hospitalization for vaso-occlusive pain crisis or acute chest syndrome in last 4 weeks
- Blood transfusion in the last 3 months
- Individuals with signs, symptoms or EKG findings of acute myocardial ischemia, infarction or unstable angina
- Individuals with history of VT/VF or SVT
- Previous cardiac surgery
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 |
|---|---|---|
| [13N]NH3Also: [N-13] Ammonia, azane, CAS# 34819-78-8Ammonia N 13 (a radioactive tracer) will be given per intravenous (IV) injection for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. | Drug | Stratum A, Stratum B, Stratum C |
| LexiscanAlso: RegadenosonGiven IV prior to PET stress test | Drug | Stratum A, Stratum B, Stratum C |
| Positron emission tomographyAlso: PETParticipants will complete a onetime PET (stress-rest) myocardial perfusion scan. | Diagnostic test | Stratum A, Stratum B, Stratum C |
Primary outcome
Mean and standard deviation of coronary flow reserve (CFR)
Time frame: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)
We will estimate the mean and standard deviation of CFR, as measured by PET myocardial blood flow reserve imaging, in young adult SCD patients with and without diastolic dysfunction and healthy controls.
CFR difference among Stratum A, Stratum B, and Stratum C
Time frame: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)
We will compare whether the CFR is different among 3 predefined strata: Stratum A; SCD with diastolic dysfunction patients , Stratum B; SCD without dysfunction patient control, and Stratum C; normal healthy controls by one-way ANOVA or Kruskal-Wallis one-way analysis of variance, depending on the distribution of the data. If the difference exists, the pairwise comparison will be carried out by two sample t test or Wilcoxon rank sum test between two strata.
1 secondary outcome
Relationship between decreased CFR (quantified with PET stress-rest myocardial perfusion imaging) and presence of abnormal diastolic parameters
Time frame: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- ClinicalTrials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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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.
Parul Rai, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [13N]NH3, Lexiscan and Positron emission tomography in people with Sickle Cell Disease, run by St. Jude Children's Research Hospital at 1 site 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 3 inclusion and 47 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Parul Rai, MD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean and standard deviation of coronary flow reserve (CFR) (time frame: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2026.