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

NCT02240979 | Completed

• 2 other identifiers: HMRI-10Pico-1CIT2014
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Keywords

arterial waveform; cardiac magnetic resonance imaging; echocardiography; intrinsic frequency measures of cardiac function

Outcome Measures

Primary Outcomes (1)

• Magnetic resonance measures of cardiac function

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

  Within 1 month of study

Study Arms (1)

Adults able to undergo cardiac MRI exam

Adults able to undergo cardiac MRI

Device: cardiac MRI

Interventions

cardiac MRI DEVICE

cardiac MRI

Adults able to undergo cardiac MRI exam

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with normal and abnormal cardiac function will be studied.

You may qualify if:

• Adult age 18-90, outpatients

You may not qualify if:

• 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

Sponsors & Collaborators

• Marie Csete MD, PhD: lead
• University of Southern California: collaborator
• California Institute of Technology: collaborator

Study Sites (2)

Avicena LLC

Pasadena, California, 91105, United States

Location

Huntington Medical Research Institutes MR Imaging Center

Pasadena, California, 91105, United States

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Marie Csete, MD, PhD

  Avicena LLC

  STUDY CHAIR

• Niema Pahlevan, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Scientific Officer

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 16, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)