Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET
- Conditions
- Sickle Cell Disease
- Interventions
- Registration Number
- NCT05583721
- Lead Sponsor
- St. Jude Children's Research Hospital
- Brief 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
- Detailed Description
This study requires two visits. The first visit includes blood tests, an electrocardiogram (EKG), and an echocardiogram. The second visit includes a positron emission tomography (PET) stress test and a blood test.
Subjects will be considered off-study one week after all post PET imaging study tests have been completed along with the next day and one-week follow-up phone calls are completed.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stratum B Positron emission tomography Sickle cell patients without diastolic dysfunction Stratum A [13N]NH3 Sickle Cell patients with diastolic dysfunction Stratum A Lexiscan Sickle Cell patients with diastolic dysfunction Stratum C [13N]NH3 Healthy controls Stratum C Lexiscan Healthy controls Stratum C Positron emission tomography Healthy controls Stratum A Positron emission tomography Sickle Cell patients with diastolic dysfunction Stratum B [13N]NH3 Sickle cell patients without diastolic dysfunction Stratum B Lexiscan Sickle cell patients without diastolic dysfunction
- Primary Outcome Measures
Name Time Method Mean and standard deviation of coronary flow reserve (CFR) Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour) 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.
CFR difference among Stratum A, Stratum B, and Stratum C Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour) We will compare whether the CFR is different among 3 predefined strata: Stratum A; SCD with diastolic dysfunction patients , Stratum B; SCD without dysfunction patient control, and Stratum C; normal healthy controls by one-way ANOVA or Kruskal-Wallis one-way analysis of variance, depending on the distribution of the data. If the difference exists, the pairwise comparison will be carried out by two sample t test or Wilcoxon rank sum test between two strata.
- Secondary Outcome Measures
Name Time Method Relationship between decreased CFR (quantified with PET stress-rest myocardial perfusion imaging) and presence of abnormal diastolic parameters Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour) The following is the grouping of diastolic parameters used in this study: Group 1: 0 or any 1 diastolic variable abnormal; Group 2: Any 2 variables abnormal; Group 3: Any 3 or more variables abnormal . We will first summarize the mean and standard deviation CFR values for each diastolic group. One-way ANOVA or Kruskal-Wallis one-way ANOVA will be used to explore whether there are any statistically significant differences between the means of these three groups. If a difference exists, the pairwise comparison will be carried out by two sample t test or Wilcoxon rank sum test between two groups.
Trial Locations
- Locations (1)
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States