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PET Imaging for Heart Function in Sickle Cell Disease

Phase 2
Recruiting
Led By Parul Rai, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how heart flow differs in SCD patients vs healthy people under stress to see if decreased blood flow is causing heart damage in SCD patients.

Who is the study for?
This trial is for adults aged 18-21 with Sickle Cell Disease (SCD) and heart dysfunction, specifically those with abnormal diastolic parameters. It includes three groups: SCD patients with diastolic dysfunction, those without it, and healthy black individuals as controls.
What is being tested?
The study aims to measure blood flow reserve in the heart using PET scans during rest and stress conditions. Researchers will compare results between SCD patients with varying levels of heart function and healthy people to understand the cause of heart damage in SCD.
What are the potential side effects?
[13N]NH3 and Lexiscan used in PET imaging may cause brief discomfort or reactions like headache, dizziness, nausea, or flushing. The risk is generally low but varies by individual.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CFR difference among Stratum A, Stratum B, and Stratum C
Mean and standard deviation of coronary flow reserve (CFR)
Secondary study objectives
Positron-Emission Tomography

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Stratum CExperimental Treatment3 Interventions
Healthy controls
Group II: Stratum BExperimental Treatment3 Interventions
Sickle cell patients without diastolic dysfunction
Group III: Stratum AExperimental Treatment3 Interventions
Sickle Cell patients with diastolic dysfunction
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lexiscan
2010
Completed Phase 2
~70
Positron emission tomography
2009
Completed Phase 2
~310

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
443 Previous Clinical Trials
5,305,411 Total Patients Enrolled
Parul Rai, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

Stratum B Clinical Trial Eligibility Overview. Trial Name: NCT05583721 — Phase 2
Sickle Cell Disease Research Study Groups: Stratum B, Stratum A, Stratum C
Sickle Cell Disease Clinical Trial 2023: Stratum B Highlights & Side Effects. Trial Name: NCT05583721 — Phase 2
Stratum B 2023 Treatment Timeline for Medical Study. Trial Name: NCT05583721 — Phase 2
~15 spots leftby Sep 2025
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