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

City of Hope

Status: Active, not recruiting

Conditions: Malignant Neoplasm

Treatments: Procedure: Diagnostic Imaging; Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04014231

15317 (Other Identifier)

NCI-2015-01612 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 1 patient group

Observational (single wave assessment)

Description:

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

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Diagnostic Imaging