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

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

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).

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Diagnostic Imaging

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.

• Study Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing 2D echocardiogram at City of Hope

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (single wave assessment); Patients undergo placement of a single wave application near the carotid region of the neck.	Other: Laboratory Biomarker Analysis; Correlative studies; Procedure: Diagnostic Imaging; Undergo placement of single wave application; Other Names: Medical Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single wave measure of insulin resistance (delta omega) and markers of inflammation	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.	Up to end of single wave assessment
Difference in left ventricular ejection fraction (LVEF) measured by the single wave application and 2D echocardiography	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.	Up to end of single wave assessment

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Joanne E Mortimer, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2017
• Primary Completion (Actual): April 20, 2026
• Study Completion (Actual): April 20, 2026

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Neoplasms; Physical Phenomena; Electromagnetic Phenomena; Magnetic Phenomena; Electromagnetic Radiation; Radiation; Radiation, Ionizing; X-Rays
• Other Study ID Numbers: 15317 (Other Identifier: City of Hope Comprehensive Cancer Center); NCI-2015-01612 (Registry Identifier: CTRP (Clinical Trial Reporting Program))