## Protocol Section
### Identification Module
**NCT ID:** NCT02240979

**Brief Title:** Establishing a Non-invasive Method to Measure Your Heart's Performance

**Official Title:** Establishing a Non-invasive Method to Measure Heart Performance

#### Organization Study ID Info
**ID:** HMRI-10Pico-1
#### Organization
**Class:** OTHER
**Full Name:** Huntington Medical Research Institutes
#### Secondary ID Infos
**Domain:** California Institute of Technology Boswell Fellowship
**ID:** CIT2014
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2019-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2019-05-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-05

**Type:** ACTUAL

#### Start Date
**Date:** 2014-08

**Type:** ACTUAL

**Status Verified Date:** 2019-05

#### Study First Post Date
**Date:** 2014-09-16
**Type:** ESTIMATED
**Study First Submit Date:** 2014-09-12
**Study First Submit QC Date:** 2014-09-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Southern California

**Class:** OTHER

**Name:** California Institute of Technology

#### Lead Sponsor

**Class:** OTHER

**Name:** Marie Csete MD, PhD

#### Responsible Party

**Investigator Affiliation:** Huntington Medical Research Institutes

**Investigator Full Name:** Marie Csete MD, PhD

**Investigator Title:** Chief Scientific Officer

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** 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 Module

**Conditions:**

- Heart Failure

**Keywords:**

- arterial waveform

- cardiac magnetic resonance imaging

- echocardiography

- intrinsic frequency measures of cardiac function

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 72

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Adults able to undergo cardiac MRI

**Intervention Names:**

- Device: cardiac MRI

**Label:** Adults able to undergo cardiac MRI exam

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Adults able to undergo cardiac MRI exam

**Description:** cardiac MRI

**Name:** cardiac MRI

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Magnetic resonance measures of cardiac function

**Time Frame:** Within 1 month of study

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adults with normal and abnormal cardiac function will be studied.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Pasadena

**Country:** United States

**Facility:** Avicena LLC

**State:** California

**Zip:** 91105

**Location 2:**

**City:** Pasadena

**Country:** United States

**Facility:** Huntington Medical Research Institutes MR Imaging Center

**State:** California

**Zip:** 91105

#### Overall Officials

**Official 1:**

**Affiliation:** Avicena LLC

**Name:** Marie Csete, MD, PhD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** University of Southern California

**Name:** Niema Pahlevan, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** A manuscript was submitted in February 2016 reporting results of the study. In editorial process.

**IPD Sharing:** YES

### References Module

#### References

**Citation:** Pahlevan NM, Tavallali P, Rinderknecht DG, Petrasek D, Matthews RV, Hou TY, Gharib M. Intrinsic frequency for a systems approach to haemodynamic waveform analysis with clinical applications. J R Soc Interface. 2014 Sep 6;11(98):20140617. doi: 10.1098/rsif.2014.0617.

**PMID:** 25008087

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-24
