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)
St. Jude Children's Research Hospital
40 participants
Oct 10, 2023
INTERVENTIONAL
Conditions
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. 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
Eligibility
Inclusion Criteria11
- 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)
- to 21 years of age
- Black
- Diagnosis of SCD of HbSS and HbSβ0thalassemia genotypes
- Two or less abnormal diastolic parameters
- to 21 years of age
- Black
- Two or less abnormal diastolic parameters
Exclusion Criteria47
- 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.
- 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.
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Interventions
Ammonia N 13 (a radioactive tracer) will be given per intravenous (IV) injection for diagnostic purposes in conjunction with positron emission tomography (PET) imaging.
Given IV prior to PET stress test
Participants will complete a onetime PET (stress-rest) myocardial perfusion scan.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05583721