Comparison Study of Non-invasive Measurement of Blood Pressure and Cardiac Output During Stress Echocardiography
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02422342|
Recruitment Status : Active, not recruiting
First Posted : April 21, 2015
Last Update Posted : February 22, 2019
|Condition or disease||Intervention/treatment|
|High Cardiac Output Low Cardiac Output||Device: Pulse Oximeter CMS50FW (Contec Medical)|
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.
- 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|
|Estimated Enrollment :||50 participants|
|Official Title:||Comparison Study of Non-invasive Measurement of Blood Pressure and Cardiac Output During Stress Echocardiography|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
- 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
- Cardiac Output [ Time Frame: Change from Baseline in Cardiac Output at 30 minutes ]Measurement of Cardiac Output at the beginning and the end of the test (30 minutes)
- Blood Pressure [ Time Frame: Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes ]
- Heart rate [ Time Frame: Change from Baseline in heart rate at 30 minutes ]Measurement of Systolic and Diastolic blood pressure at the beginning and the end of the test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422342
|Meir Health Center|
|Kfar Saba, Israel, 4428164|
|Principal Investigator:||Yoram Neuman, MD||Meir Health Facility|