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

NCT04014231 | Active Not Recruiting DMC

• 2 other identifiers: 15317NCI-2015-01612
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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).

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Observational (single wave assessment)

Patients undergo placement of a single wave application near the carotid region of the neck.

Procedure: Diagnostic Imaging; Other: Laboratory Biomarker Analysis

Interventions

Diagnostic Imaging PROCEDURE

Undergo placement of single wave application

Also known as: Medical Imaging

Observational (single wave assessment)

Laboratory Biomarker Analysis OTHER

Correlative studies

Observational (single wave assessment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing 2D echocardiogram at City of Hope

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Joanne E Mortimer

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: July 10, 2019
• Study Start: July 21, 2017
• Primary Completion (Estimated): May 11, 2026
• Study Completion (Estimated): May 11, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

US (1)