Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Oct 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how reduced blood flow to the heart might be related to heart problems in people with Sickle Cell Disease (SCD). Specifically, researchers want to understand if this reduced blood flow during physical stress can contribute to heart damage. They will compare SCD patients, some with heart function issues and some without, to healthy individuals to see how their hearts respond under stress.

To participate, you need to be between 18 and 21 years old and identify as Black. If you have SCD, you should either have three or more heart function abnormalities or two or fewer to qualify for the study. Healthy volunteers must also have two or fewer abnormalities. Participants will undergo a special imaging test called PET (Positron Emission Tomography) to assess heart blood flow during stress and rest. This trial is currently recruiting participants, so if you meet the criteria and are interested, this could be a valuable opportunity to contribute to understanding heart health in SCD.

Gender

ALL

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.