NCT05583721 · St. Jude Children's Research Hospital
Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
[13N]NH3
Ammonia N 13 (a radioactive tracer) will be given per intravenous (IV) injection for diagnostic purposes in conjunction with positron emission tomography (PET) imaging.
DRUG
Lexiscan
Given IV prior to PET stress test
DIAGNOSTIC_TEST
Positron emission tomography
Participants will complete a onetime PET (stress-rest) myocardial perfusion scan.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- - Stratum A: Sickle cell patients with diastolic dysfunction
- 18 to 21 years of age
- Diagnosis of SCD of HbSS and HbSβ0thalassemia genotypes
- Three or more abnormal diastolic parameters (based on guidelines by American Society of echocardiography) Inclusion Criteria - Stratum B: Sickle cell patients without diastolic dysfunction
- 18 to 21 years of age
- Diagnosis of SCD of HbSS and HbSβ0thalassemia genotypes
- Two or less abnormal diastolic parameters Inclusion Criteria - Stratum C: Healthy controls
- 18 to 21 years of age
- Two or less abnormal diastolic parameters
Exclusion criteria
- - Stratum A:
- 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. Exclusion Criteria - Stratum B:
- 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. Exclusion Criteria - Stratum C:
- 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.
Where
- Memphis, Tennessee
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations