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NCT Number: NCT05583721

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

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

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location status: Recruiting

Location contact

Parul Rai, MD

CONTACT

[email protected]

888-226-4343

Parul Rai, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[13N]NH3

Drug

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

Lexiscan

Drug

Given IV prior to PET stress test

Other names: Regadenoson

Positron Emission Tomography

Diagnostic Test

Participants will complete a onetime PET (stress-rest) myocardial perfusion scan.

Other names: PET

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Parul Rai, MD

CONTACT

[email protected]

888-226-4343

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 18, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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