Early Imaging Detection of Cardiovascular Injury After Cancer
I. To design an automated MRI hardware/software platform for measuring and reporting left
ventricular (LV) function (volumes, strain, and ejection fraction [EF]), T1 myocardial
signal, and aortic pulse wave velocity (PWV).
II. To determine if pre- to 3 month post-anthracycline-based chemotherapy (Anth-bC) changes
in our MRI platform generated measures of LV volumes, EF, strain, myocardial T1, and aortic
PWV predict pre- to 24 month post-Anth-bC differences in these same parameters.
Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at
baseline, 3 months, and 24 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To correlate results of an automated MRI hardware/software platform for measuring left ventricular (LV) function with manual results.
For the automation to be considered useful it should correlate highly with the manual results, exhibit a similar mean value and overall variability. 95% confidence intervals (CIs) of the difference between measures will be constructed and the upper and lower bounds of these intervals will be examined. The final diagnostic we will perform is to run F-tests to determine whether the variability from each measure is the same or different. 95% CIs will be examined for the ratio of the variance.
Up to 24 months
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Comprehensive Cancer Center of Wake Forest University||Winston-Salem, North Carolina 27157-1082|