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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT05583721
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 21 Years
Healthy Volunteers
Accepted

Interventions

  • [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.
  • Lexiscan — DRUG
    Given IV prior to PET stress test
  • Positron emission tomography — DIAGNOSTIC_TEST
    Participants will complete a onetime PET (stress-rest) myocardial perfusion scan.

Study Details

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

Key Dates

Start date
Oct 10, 2023
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Stratum A
    Sickle Cell patients with diastolic dysfunction
  • Experimental: Stratum B
    Sickle cell patients without diastolic dysfunction
  • Experimental: Stratum C
    Healthy controls

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Parul Rai, MD
[email protected]
888-226-4343
Parul Rai, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Memphis, TN

By condition
Sickle cell disease
By research site
St. Jude Children's Research Hospital· Memphis, TN

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