NCT05583721 Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 40 participants in total. It began in 2023-10-10 with a primary completion date of 2027-09.

Brief 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 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.

Contact & Investigator

Frequently Asked Questions

Related Trials

Related Intelligence Guides

In-depth guides covering this condition's trials, eligibility, and what to expect.