Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET
Recruiting · NCT05583721 · Interventional (participants receive a specific treatment) · Lead sponsor: St. Jude Children's Research Hospital
View the official record on ClinicalTrials.gov →Interventions studied
LexiscanPositron emission tomography[13N]NH3
What this trial is about
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
Who can take part
Age range
18 Years to 21 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- St. Jude Children's Research Hospital - Memphis, Tennessee, United States