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

Low Cardiac Output Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02422342
• Other study ID #: HeartBeat_V2.0_SE
• Status: Active, not recruiting
• Start date: April 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2019
• Source: HeartBeat Technologies LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output, High
• Cardiac Output, Low
• High Cardiac Output
• Low Cardiac Output

Intervention

Device:
• Pulse Oximeter CMS50FW (Contec Medical)
The patients will be wearing the pulse oximeter during the test period (20-30 minutes). The data from the oximeter will be sent by Bluetooth to the mobile application

Locations

Country	Name	City	State
Israel	Meir Health Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
HeartBeat Technologies LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood Pressure		Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes
Secondary	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