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

StatusRecruiting
PhasePhase 2
Started2023-10-10
View on ClinicalTrials.gov ↗

Amendment history

2026-05-01
Study Status, Contacts/Locations v19
Study sitescontacts updated at 1 of 1 site
2025-12-03
2 amendments v17-v18
2 re-verifications since 2025-07-14, no change to tracked fields
2025-01-17
Study Status, Eligibility v16
Primary completion date2025-09→2027-09
Completion date2026-09→2028-09
Eligibility criteria-17 characters
[...] ased on guidelines by American Society of echocardiography) IndividualAnemia withof hemoglobingrade level2 belowor theworse normal(per rangeCTCAE forv5.0) thatat agestudy andvisit sex1 Individuals with signs, symptoms or EKG findings of acute m [...] t ventricle systolic dysfunction Cardiovascular instability/uncontro lleduncontrolled hypertension (h/o hypertensive urgency or emergency) Histor [...]
2024-10-09
2 amendments v14-v15
2 re-verifications since 2024-02-29, no change to tracked fields
2023-10-24
Study Status v13
Start dateestimated 2023-10→confirmed 2023-10-10
Show 12 earlier versions
2023-09-14
Study Status v12
Start date2023-09→2023-10
2023-08-18
Study Status v11
Start date2023-08→2023-09
2023-07-07
Study Status v10
Start date2023-07→2023-08
2023-06-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v9
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2023-06-02
Study Status v8
Start date2023-06→2023-07
2023-05-23
Study Status v7
Start date2023-05→2023-06
2023-04-03
Study Status v6
Start date2023-04→2023-05
2023-03-22
Study Status v5
Start date2023-03→2023-04
2023-02-22
Study Status v4
Start date2023-02→2023-03
2023-01-11
Study Status v3
Start date2023-01→2023-02
2022-12-19
Study Status v2
Start date2022-12→2023-01
2022-11-08
Study Status v1
Start date2022-10→2022-12
2022-10-13
Original filing
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
Trial Details
NCT Number NCT05583721
Lead Sponsor St. Jude Children's Research Hospital
Conditions Sickle Cell Disease
Enrollment 40 participants
Start Date 2023-10-10
Primary Completion 2027-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-06