Skip to main content
OpenTrials
Completed

NCT Number: NCT04014231

Novel Single Wave Assessment in Measuring Cardiac Dysfunction and Metabolic Syndrome in Patients With Cancer

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic Imaging

Procedure

Undergo placement of single wave application

Other names: Medical Imaging

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Single wave measure of insulin resistance (delta omega) and markers of inflammation

    Time frame: 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.

  2. Difference in left ventricular ejection fraction (LVEF) measured by the single wave application and 2D echocardiography

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Novel Single Wave Assessment to Measure Cardiac Dysfunction and Metabolic Syndrome in Cancer Patients

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2019
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.