Establishing a Non-invasive Method to Measure Your Heart'... | NCT02240979

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

NCT02240979

Sponsor

Marie Csete MD, PhD

Status

Completed

Last Update Posted

May 14, 2019Actual

Enrollment

72Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

cardiac MRI

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CIT2014	Other Identifier	California Institute of Technology Boswell Fellowship

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014Actual

Primary Completion Date

May 2019Actual

Completion Date

May 2019Actual

First Submitted Date

Sep 12, 2014

First Submission Date that Met QC Criteria

Sep 15, 2014

First Posted Date

Sep 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2019

Last Update Posted Date

May 14, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marie Csete MD, PhD, Chief Scientific Officer, Huntington Medical Research InstitutesSponsor-Investigator

Lead Sponsor

Marie Csete MD, PhDOTHER

Collaborators

Name	Class
University of Southern California	OTHER
California Institute of Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adults able to undergo cardiac MRI exam		Adults able to undergo cardiac MRI	Device: cardiac MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiac MRI	Device	cardiac MRI	Adults able to undergo cardiac MRI exam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Magnetic resonance measures of cardiac function	Standard end-points of cardiac function such as chamber size and relaxation.	Within 1 month of study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Adults with normal and abnormal cardiac function will be studied.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie Csete, MD, PhD	Ventric Health, LLC	Study Chair
Niema Pahlevan, PhD	University of Southern California	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Avicena LLC		Pasadena	California	91105	United States
Huntington Medical Research Institutes MR Imaging Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25008087	Background	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.
41669977	Derived	Niroumandi S, Rinderknecht D, Bilgi C, Cole S, Ogbonnaya SA, Wolfson AM, Vaidya AS, King KS, Pahlevan NM. Smartphone Measurement of Aortic Arch Pulse-Wave Velocity and Total Arterial Compliance: Accessible Local and Global Arterial Stiffness Assessment. J Am Heart Assoc. 2026 Feb 17;15(4):e043563. doi: 10.1161/JAHA.125.043563. Epub 2026 Feb 11.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases