Investigating heart blood flow and function in sickle cell disease
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)
Run by St. Jude Children's Research Hospital · NCT05583721 · Data updated 2026-11-12
This study is testing how blood flow and heart function are affected in people with sickle cell disease to see if it leads to heart problems.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 21 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Status | Recruiting |
| Started | October 10, 2023 |
| Main results expected | September 2027 |
| Study ends | September 2028 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT05583721 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include Black individuals aged 18 to 21 with Sickle Cell Disease, either with or without diastolic dysfunction.
✕Probably not a fit
Patients who have had recent hospitalizations for vaso-occlusive crises or acute chest syndrome may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to explore the relationship between abnormal myocardial perfusion and diastolic dysfunction in patients with Sickle Cell Disease (SCD) using positron emission tomography (PET). It involves two visits where participants undergo blood tests, an electrocardiogram (EKG), echocardiogram, and a PET stress test. The primary objective is to estimate coronary flow reserve (CFR) in SCD patients with and without diastolic dysfunction compared to healthy controls. The study seeks to understand how decreased blood flow during stress may contribute to heart damage in SCD patients.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of heart complications in patients with Sickle Cell Disease.
How similar studies have gone: While there is limited information on similar studies, the approach of using PET imaging to assess myocardial perfusion in SCD is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria - Stratum A: Sickle cell patients with diastolic dysfunction * 18 to 21 years of age * Black * 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 * Black * 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 * Black * 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 it's running
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States Recruiting
Study contacts
- Principal investigator: Parul Rai, MD — St. Jude Children's Research Hospital
- Study coordinator: Parul Rai, MD
- Email: referralinfo@stjude.org
- Phone: 888-226-4343
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.