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

NCT ID: NCT04014231

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-21

Study Completion Date

2026-05-11

Brief Summary

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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

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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

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Malignant Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (single wave assessment)

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

Diagnostic Imaging

Intervention Type PROCEDURE

Undergo placement of single wave application

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Diagnostic Imaging

Undergo placement of single wave application

Intervention Type PROCEDURE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Medical Imaging

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne E Mortimer

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2015-01612

Identifier Type: REGISTRY

Identifier Source: secondary_id

15317

Identifier Type: OTHER

Identifier Source: secondary_id

15317

Identifier Type: -

Identifier Source: org_study_id

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