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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CFR difference among Stratum A, Stratum B, and Stratum C

Mean and standard deviation of coronary flow reserve (CFR)

Secondary outcome measures

Positron-Emission Tomography

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

Positron emission tomography

2009

Completed Phase 2

~310

Lexiscan

2010

Completed Phase 2

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,573 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Stratum C for medical use?

"While there is some evidence that Stratum C is safe, it is only from a Phase 2 trial, so it received a score of 2."

Answered by AI

Are research facilities still signing up participants for this experiment?

"This particular clinical trial, as indicated on clinicaltrials.gov, is not taking on new patients at the moment. However, it is worth noting that the trial's last update was on October 13th, 2022 and that there are 200 other trials with open enrollment currently."

Answered by AI

Might I be a candidate to sign up for this research project?

"The trial is looking for 40 participants, aged 18 to 21, who have anemia or sickle cell. Patients must also meet the following criteria: Inclusion Criteria - Stratum A: Sickle cell patients with diastolic dysfunction, 18 to 21 years of age, Diagnosis of SCD of HbSS and HbSβ0thalassemia genotypes, Three or more abnormal diastolic parameters (based on guidelines by American Society of echocardiography), Black, Inclusion Criteria - Stratum B: Sickle cell patients without diastolic dysfunction, Two or less abnormal di"

Answered by AI