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

May 1, 2026 updated by: St. Jude Children's Research Hospital

An Evaluation of the Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET (Stress-Rest) Myocardial Perfusion Imaging (MYPERS)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study requires two visits. The first visit includes blood tests, an electrocardiogram (EKG), and an echocardiogram. The second visit includes a positron emission tomography (PET) stress test and a blood test.

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Children's Research Hospital
        • Principal Investigator:
          • Parul Rai, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 21 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stratum A
Sickle Cell patients with diastolic dysfunction
Drug: [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.
Other Names:
  • [N-13] Ammonia
  • azane
  • CAS# 34819-78-8
Drug: Lexiscan
Given IV prior to PET stress test
Other Names:
  • Regadenoson
Diagnostic test: Positron emission tomography
Participants will complete a onetime PET (stress-rest) myocardial perfusion scan.
Other Names:
  • PET
Experimental: Stratum B
Sickle cell patients without diastolic dysfunction
Drug: [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.
Other Names:
  • [N-13] Ammonia
  • azane
  • CAS# 34819-78-8
Drug: Lexiscan
Given IV prior to PET stress test
Other Names:
  • Regadenoson
Diagnostic test: Positron emission tomography
Participants will complete a onetime PET (stress-rest) myocardial perfusion scan.
Other Names:
  • PET
Experimental: Stratum C
Healthy controls
Drug: [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.
Other Names:
  • [N-13] Ammonia
  • azane
  • CAS# 34819-78-8
Drug: Lexiscan
Given IV prior to PET stress test
Other Names:
  • Regadenoson
Diagnostic test: Positron emission tomography
Participants will complete a onetime PET (stress-rest) myocardial perfusion scan.
Other Names:
  • PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean and standard deviation of coronary flow reserve (CFR)
Time Frame: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)
We will estimate the mean and standard deviation of CFR, as measured by PET myocardial blood flow reserve imaging, in young adult SCD patients with and without diastolic dysfunction and healthy controls.
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)
We will compare whether the CFR is different among 3 predefined strata: Stratum A; SCD with diastolic dysfunction patients , Stratum B; SCD without dysfunction patient control, and Stratum C; normal healthy controls by one-way ANOVA or Kruskal-Wallis one-way analysis of variance, depending on the distribution of the data. If the difference exists, the pairwise comparison will be carried out by two sample t test or Wilcoxon rank sum test between two strata.
Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between decreased CFR (quantified with PET stress-rest myocardial perfusion imaging) and presence of abnormal diastolic parameters
Time Frame: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)
The following is the grouping of diastolic parameters used in this study: Group 1: 0 or any 1 diastolic variable abnormal; Group 2: Any 2 variables abnormal; Group 3: Any 3 or more variables abnormal . We will first summarize the mean and standard deviation CFR values for each diastolic group. One-way ANOVA or Kruskal-Wallis one-way ANOVA will be used to explore whether there are any statistically significant differences between the means of these three groups. If a difference exists, the pairwise comparison will be carried out by two sample t test or Wilcoxon rank sum test between two groups.
Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Parul Rai, MD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYPERS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

IPD Sharing Time Frame

Data will be made available at the time of article publication.

IPD Sharing Access Criteria

Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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