Recruiting
Phase 2

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT05583721

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 18 - 21

Healthy Volunteers: Accepted

Interventions

[13N]NH3

Lexiscan

Positron emission tomography

Study Details

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

Conditions

Sickle Cell Disease

Study ID

NCT05583721

Start date

Oct 10, 2023

Status verified date

May, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 21

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Stratum A

Sickle Cell patients with diastolic dysfunction

experimental: Stratum B

Sickle cell patients without diastolic dysfunction

experimental: Stratum C

Healthy controls

Interventions

[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.

Primary outcome measure

  • Mean and standard deviation of coronary flow reserve (CFR) [ Time Frame: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour) ]
  • CFR difference among Stratum A, Stratum B, and Stratum C [ Time Frame: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour) ]

Central Contacts and Locations

Central contacts

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Principal Investigator:

Parul Rai, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Sickle Cell Disease patients
  • Healthy controls
  • Abnormal diastolic heart function
  • Coronary Flow Reserve (CFR)
  • Coronary microvasculature dysfunction
  • Myocardial perfusion reserve
  • Positron emission tomography (PET) imaging
  • PET (stress-rest) myocardial perfusion imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-05-06.