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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04014231
• Other study ID #: 15317
• Secondary ID: NCI-2015-0161215
• Status: Active, not recruiting
• Start date: July 21, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Metabolic Syndrome
• Neoplasms

Intervention

Procedure:
• Diagnostic Imaging
Undergo placement of single wave application

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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