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

Sponsor
Marie Csete MD, PhD (Other)
Overall Status
Completed
CT.gov ID
NCT02240979
Collaborator
University of Southern California (Other), California Institute of Technology (Other)
72
2
57
36
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: cardiac MRI

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.

Study Design

Study Type:
Observational
Actual Enrollment :
72 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Establishing a Non-invasive Method to Measure Heart Performance
Actual Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Adults able to undergo cardiac MRI exam

Adults able to undergo cardiac MRI

Device: cardiac MRI
cardiac MRI

Outcome Measures

Primary Outcome Measures

  1. Magnetic resonance measures of cardiac function [Within 1 month of study]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Avicena LLC Pasadena California United States 91105
2 Huntington Medical Research Institutes MR Imaging Center Pasadena California United States 91105

Sponsors and Collaborators

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

Investigators

  • Study Chair: Marie Csete, MD, PhD, Avicena LLC
  • Principal Investigator: Niema Pahlevan, PhD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marie Csete MD, PhD, Chief Scientific Officer, Huntington Medical Research Institutes
ClinicalTrials.gov Identifier:
NCT02240979
Other Study ID Numbers:
  • HMRI-10Pico-1
  • CIT2014
First Posted:
Sep 16, 2014
Last Update Posted:
May 14, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Marie Csete MD, PhD, Chief Scientific Officer, Huntington Medical Research Institutes
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 14, 2019