Establishing a Non-invasive Method to Measure Your Heart's Performance

The purpose of the study is to evaluate a new way to examine cardiac function, using software developed at Caltech. The experimental device is software loaded on an iPhone. The iPhone is used to capture a pulse (waveform) by simply placing the iPhone lightly over the neck where the carotid pulse can be felt. In this study the information collected from the iPhone app is compared to cardiac function data obtained from the current gold standard for measuring cardiac function, cardiac magnetic resonance imaging (MRI). Subjects referred from cardiologists will also generally have echocardiography information available for comparison with the iPhone app. For the study, subjects will have completely non-invasive studies done in one setting: The iPhone app to capture the waveforms (over carotid and radial (wrist) arteries), tonometry (another non-invasive method using a modified stethoscope), standard pulse oximetry, followed by a 30 minute MRI examination of the heart. A second complete study will be done about 6 months after the first. The complete study session takes about 1.5 hours.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Avicena LLC, Pasadena, California, United States

About this study

Investigators at Caltech have developed an iPhone-based application that allows them to capture an arterial waveform using the iPhone camera held over the skin. Then based on the captured waveform and previous laboratory experiments and models, the investigators are able to calculate ejection fraction, the percentage of blood that goes out of the heart into the circulation with each beat. Previous studies suggested that the iPhone app measurements of ejection fraction were similar to those obtained with traditional cardiac echocardiography. In the current study the iPhone app measures are being compared to ejection fraction obtained using cardiac MRI. The iPhone also measures other physical properties of the heart and aorta that the investigators call "intrinsic frequencies". Using healthy subjects they have established the normal pattern/range of intrinsic frequencies, and in this study, a more diverse population of subjects (some with heart disease) will be studied, to determine how intrinsic frequency measures compare to traditional clinical measures of cardiac function.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult age 18-90, outpatients

Exclusion criteria

Inability to lie flat for 30 minutes with periodic breath holding
Metal implants or other standard contraindications to MRI
Acute cardiac decompensation (active chest pain, shortness of breath)
Hypotension (SBP<90 mm Hg)
Claustrophobia
Patient too large to fit in closed MRI

Treatment and study plan

Cardiac MRI

Device

cardiac MRI

Primary outcomes

Magnetic resonance measures of cardiac function

Time frame: Within 1 month of study

Standard end-points of cardiac function such as chamber size and relaxation.

Sponsors and collaborators

Lead sponsor

Marie Csete MD, PhD

Other

Collaborators

California Institute of Technology
University of Southern California

Registry information

Official study title

Establishing a Non-invasive Method to Measure Heart Performance

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2019
First posted: Sep 16, 2014
Registry last updated: May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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