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

Sponsor
St. Jude Children's Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05583721
Collaborator
(none)
40
Enrollment
1
Location
3
Arms
43
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official 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)
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean and standard deviation of coronary flow reserve (CFR) [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 [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 Outcome Measures

    1. Relationship between decreased CFR (quantified with PET stress-rest myocardial perfusion imaging) and presence of abnormal diastolic parameters [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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)

    • Individual with hemoglobin level below the normal range for that age and sex

    • 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/uncontro lled 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Jude Children's Research Hospital Memphis Tennessee United States 38105

    Sponsors and Collaborators

    • St. Jude Children's Research Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    St. Jude Children's Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05583721
    Other Study ID Numbers:
    • MYPERS
    First Posted:
    Oct 18, 2022
    Last Update Posted:
    Jan 12, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by St. Jude Children's Research Hospital
    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
    Additional relevant MeSH terms:
    Anemia, Sickle Cell
    Regadenoson

    Study Results

    No Results Posted as of Jan 12, 2023