Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET
NCT ID: NCT05583721
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2023-10-10
2028-09-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Stratum A
Sickle Cell patients with diastolic dysfunction
[13N]NH3
Ammonia N 13 (a radioactive tracer) will be given per intravenous (IV) injection for diagnostic purposes in conjunction with positron emission tomography (PET) imaging.
Lexiscan
Given IV prior to PET stress test
Positron emission tomography
Participants will complete a onetime PET (stress-rest) myocardial perfusion scan.
Stratum B
Sickle cell patients without diastolic dysfunction
[13N]NH3
Ammonia N 13 (a radioactive tracer) will be given per intravenous (IV) injection for diagnostic purposes in conjunction with positron emission tomography (PET) imaging.
Lexiscan
Given IV prior to PET stress test
Positron emission tomography
Participants will complete a onetime PET (stress-rest) myocardial perfusion scan.
Stratum C
Healthy controls
[13N]NH3
Ammonia N 13 (a radioactive tracer) will be given per intravenous (IV) injection for diagnostic purposes in conjunction with positron emission tomography (PET) imaging.
Lexiscan
Given IV prior to PET stress test
Positron emission tomography
Participants will complete a onetime PET (stress-rest) myocardial perfusion scan.
Interventions
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[13N]NH3
Ammonia N 13 (a radioactive tracer) will be given per intravenous (IV) injection for diagnostic purposes in conjunction with positron emission tomography (PET) imaging.
Lexiscan
Given IV prior to PET stress test
Positron emission tomography
Participants will complete a onetime PET (stress-rest) myocardial perfusion scan.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Black
* Diagnosis of SCD of HbSS and HbSβ0thalassemia genotypes
* Three or more abnormal diastolic parameters (based on guidelines by American Society of echocardiography)
* 18 to 21 years of age
* Black
* Diagnosis of SCD of HbSS and HbSβ0thalassemia genotypes
* Two or less abnormal diastolic parameters
* 18 to 21 years of age
* Black
* Two or less abnormal diastolic parameters
Exclusion Criteria
* 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.
18 Years
21 Years
ALL
Yes
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Parul Rai, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Central Contacts
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Related Links
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St. Jude Children's Research Hospital
ClinicalTrials Open at St. Jude
Other Identifiers
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MYPERS
Identifier Type: -
Identifier Source: org_study_id
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