Comparison Study of Non-invasive Measurement of Blood Pressure and Cardiac Output During Stress Echocardiography

The objectives of the clinical trial is to validate hemodynamic parameters (Blood pressure and Cardiac Output) generated by an application coupled with an off-the-shelf pulse oximeter. The validation will be done by comparing the generated information to data gathered while performing Stress Echocardiography. The first phase of the study will be done on 10 patients undergoing a Stress Echocardiography test at the cardiology department at Meir Hospital

Study Overview

• Status: Unknown
• Conditions: Low Cardiac Output; High Cardiac Output
• Intervention / Treatment: Device: Pulse Oximeter CMS50FW (Contec Medical)

Detailed Description

The HeartBeat system combines an FDA/CE approved watch-like Pulse Oximeter for acquiring the data and an android software application that serves as the Hemodynamic calculator. The application performs POST-PROCESSING of the PhotoPlethismoGraphic (PPG) signal (Normally the PPG signal in Pulse Oximeters is used only to compute heart rate and SpO2). The raw data is transferred from the watch oximeter to the smartphone using a standard Bluetooth protocol.

The Post-processing uses wavelet signal processing to estimate and display certain Hemodynamic parameters like Blood Pressure (BP) and Cardiac Output (CO) in a continuous and graphical way on a standard Android device. In addition to the standard heart rate and SpO2, the application displays the measured PPG signal and estimated continues BP and CO.

HeartBeat is the only device that can non-invasively estimate Continuous BP and its Cardiac Output component and the resistance component in a mobile wearable device. Differentiating between these 2 components can play a major role in helping the doctor to understand the effect of cardiovascular medications and Lifestyle interventions.

The trial will compare blood pressure and cardiac output parameters measured during Stress Echocardiography using an echo cardiograph and standard sphygmomanometer to the parameters generated by the application.

Trial goals

• Feasibility tests for the HeartBeat application as a tool for monitoring BP and CO changes over time
• Compare BP and CO parameters generated by the applications to the ones measured by standard non-invasive equipment during a Stress Echocardiography
• Calculate additional parameters such as stroke volume, systematic vascular resistance and cardiac index

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 4428164
    • Meir health center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that are referred to the Stress Echocardiography test and are not in the exclusion criteria

Description

Inclusion Criteria:

• Patients referred to an Stress Echocardiography test for cardiac diagnostics
• Male and Female
• Between 18 to 90 years old

Exclusion Criteria:

• Under the age of 18 or over 90 years old
• Patients in Shock
• Patients with Moderate or Severe valvular disease
• Patients with severe sepsis
• Inadequate jurisprudence patients
• Patients supported by Amines

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Output	Measurement of Cardiac Output at the beginning and the end of the test (30 minutes)	Change from Baseline in Cardiac Output at 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure		Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes
Heart rate	Measurement of Systolic and Diastolic blood pressure at the beginning and the end of the test	Change from Baseline in heart rate at 30 minutes

Collaborators and Investigators

• Sponsor: HeartBeat Technologies LTD
• Investigators: Principal Investigator: Yoram Neuman, MD, Meir Health Facility

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: April 13, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimate): April 21, 2015

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Output, Low; Cardiac Output, High
• Other Study ID Numbers: HeartBeat_V2.0_SE