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

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ClinicalTrials.gov Identifier: NCT02422342
Recruitment Status : Active, not recruiting
First Posted : April 21, 2015
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
HeartBeat Technologies LTD

Brief 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

Condition or disease Intervention/treatment
High Cardiac Output Low Cardiac Output 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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • 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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes ]
  2. 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients that are referred to the Stress Echocardiography test and are not in the exclusion criteria
Criteria

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

Information from the National Library of Medicine

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


Locations
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Israel
Meir Health Center
Kfar Saba, Israel, 4428164
Sponsors and Collaborators
HeartBeat Technologies LTD
Investigators
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Principal Investigator: Yoram Neuman, MD Meir Health Facility

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Responsible Party: HeartBeat Technologies LTD
ClinicalTrials.gov Identifier: NCT02422342     History of Changes
Other Study ID Numbers: HeartBeat_V2.0_SE
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Cardiac Output, Low
Cardiac Output, High
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms