Malignant Neoplasm
Conditions
Brief summary
This clinical trial studies a novel single wave assessment in measuring cardiac dysfunction and metabolic syndrome in patients with cancer. The novel single wave assessment is a hand held device that can report left ventricular ejection fraction, which measures how well the heart is pumping blood (by giving a percentage) and measures how stiff the arteries are in the heart (pulse wave velocity). A novel single wave assessment may help identify patients at increased risk for type II diabetes and metabolic syndrome (disease where patients have increased blood pressure and high blood sugar level and excess body fat around the waist and abnormal cholesterol levels).
Detailed description
PRIMARY OBJECTIVES: I. To determine the relationship between insulin resistance (delta omega) as measured by the single wave application and inflammation markers associated with insulin resistance and metabolic syndrome (MetS) in cancer patients, and to estimate the mean and standard deviation (sd) of delta omega in cancer patients with and without MetS for designing future, larger studies. II. To determine the degree of agreement between the single wave measure of left ventricular ejection fraction (LVEF) in cancer patients and that measured by the routine 2-dimensional (2D) echocardiography (standard of care). OUTLINE: Patients undergo placement of a single wave application near the carotid region of the neck.
Interventions
PROCEDUREDiagnostic Imaging
Undergo placement of single wave application
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing 2D echocardiogram at City of Hope (COH) * Patients with a current or past diagnosis of cancer * Ability to sign a written informed consent
Exclusion criteria
* Inability to provide informed consent * Patients who have known "carotid sinus hypersensitivity" * Patients who do not consent to blood draw * Patients who have not fasted for the instructed time prior to blood draw
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single wave measure of insulin resistance (delta omega) and markers of inflammation | Up to end of single wave assessment | The agreement of the single wave-based ejection fraction (EF) to EF measured by 2-dimensional (2D) echocardiography will be estimated in this study. Generalized linear models will be fitted to insulin resistance as the dependent variable and the inflammation markers as independent variables, adjusted for sex, age, and other clinical factors, along with an indicator of MetS (1 if present; 0 if absent) and the interactions of MetS and the inflammation markers to examine their association with insulin resistance. |
| Difference in left ventricular ejection fraction (LVEF) measured by the single wave application and 2D echocardiography | Up to end of single wave assessment | Initially, the measurements from the two methods will be plotted to visualize their agreement. The Bland-Altman plot will then be used to assess the degree of agreement. The difference in LVEF measured by the two methods will be plotted against the mean of the measurements from the two methods. The 95% confidence interval for the mean difference will be determined. Sensitivity and specificity of the single wave-based LVEF measure for various cutpoints of LVEF from 2D echocardiography (as the gold standard) will also be computed. Pearson correlation coefficient will be calculated. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoanne E Mortimer
City of Hope Medical Center
Outcome results
None listed