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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2019-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients

NCT04003415

Copd Asthma Respiratory Effort +1 more

COMPLETED NA

Apple Heart & Movement Study

NCT04198194

Prevention

ACTIVE_NOT_RECRUITING

Novel Wearable Device for Heart Failure Management

NCT05642650

Heart Failure

UNKNOWN NA

Remote Monitoring of Multiple Indicators of Heart Failure

NCT04267744

Heart Failure

ACTIVE_NOT_RECRUITING NA

Accuracy of Commercially Available Heart Rate Monitors II

NCT02818244

Healthy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adults able to undergo cardiac MRI exam

Adults able to undergo cardiac MRI

cardiac MRI

Intervention Type DEVICE

cardiac MRI

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cardiac MRI

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes