Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET
An Evaluation of the Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET (Stress-Rest) Myocardial Perfusion Imaging (MYPERS)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 21 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 2 visits
- Procedures mentioned: Blood draws, Heart tracing (ECG), Phone or video check-ins
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study uses PET heart scans to see whether low blood flow during stress is linked to heart damage in people with sickle cell disease (SCD). It is for Black adults ages 18 to 21 with SCD, with or without trouble relaxing the heart between beats, and healthy adults for comparison.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- All groups: Black adults ages 18 to 21.
- SCD groups: Must have the HbSS or HbSβ0 thalassemia type of sickle cell disease.
- SCD group with heart relaxation problems: At least 3 abnormal measures of how the heart relaxes between beats.
- SCD group without heart relaxation problems: No more than 2 abnormal measures of how the heart relaxes between beats.
- Healthy comparison group: No SCD and no more than 2 abnormal measures of how the heart relaxes between beats.
Who can't join
- SCD groups: Hospital stay for a sickle cell pain crisis or acute chest syndrome (a serious lung problem) in the past 4 weeks, or a blood transfusion in the past 3 months.
- Healthy group: Any type of SCD, 3 or more abnormal heart relaxation measures, or grade 2 or worse anemia (low red blood cells) at the first study visit.
- Signs of a current shortage of blood to the heart, a heart attack, or unstable angina (chest pain from poor blood flow).
- History of certain fast heart rhythms, problems with the heart's electrical signals, or a stopped heart, even if revived.
- Past heart surgery; a heart defect present at birth, except patent ductus arteriosus or atrial septal defect; narrowed heart valves; or narrowing of the left main heart artery.
- Past inflammation of the heart or its lining, weak pumping by the heart's main chamber, unstable heart or blood flow problems, or uncontrolled high blood pressure.
- A current seizure disorder treated with seizure medicine, pregnancy, or breastfeeding.
- Any medical or social reason that study doctors believe makes joining the study unwise.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.
Study sites (1)
TN
- St. Jude Children's Research Hospital · Memphis, TN 38105Parul Rai, MD · Study contact · 888-226-4343 · referralinfo@stjude.orgParul Rai, MD · Principal investigatorMore trials in Memphis