NCT04014231

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Diagnostic Imaging	Undergo placement of single wave application
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-07-21
• Primary completion: 2026-05-11
• Completion: 2026-05-11
• First posted: 2019-07-10
• Last updated: 2025-07-18

Locations

1 site across 1 country: United States