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NCT05583721 · ClinicalTrials.gov registry record · Phase 2
Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET
A Phase 2 study of Sickle Cell Disease, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05583721: Recruiting Phase 2 study of Sickle Cell Disease, sponsored by St. Jude Children's Research Hospital.
NCT05583721 is a Phase 2 study of Sickle Cell Disease that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 40 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05583721, a Phase 2 study of Sickle Cell Disease, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG [13N]NH3
- DRUG Lexiscan
- DIAGNOSTIC_TEST Positron emission tomography
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-10-10 |
| Est. Completion | 2028-09 |
| Phase | Phase 2 |
What NCT05583721 shows while recruiting
NCT05583721 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 3 interventions - of which [13N]NH3 is the first listed.
NCT05583721 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT05583721 about?
NCT05583721 is a clinical study titled "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...
What is the current status of trial NCT05583721?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2023-10-10. Estimated completion is 2028-09.
What conditions does trial NCT05583721 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT05583721?
The interventions under investigation include: [13N]NH3 (DRUG), Lexiscan (DRUG), Positron emission tomography (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05583721?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05583721 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05583721's enrollment target sits among peer trials
40 124th of 213 higher than 86 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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