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

NCT02422342 | Unknown

• 1 other identifier: HeartBeat_V2.0_SE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

High Cardiac Output; Low Cardiac Output

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Blood Pressure

  Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes

• Heart rate

  Change from Baseline in heart rate at 30 minutes

Interventions

Pulse Oximeter CMS50FW (Contec Medical) DEVICE

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• HeartBeat Technologies LTD: lead

Study Sites (1)

Meir Health Center

Kfar Saba, 4428164, Israel

Location

MeSH Terms

Conditions

Cardiac Output, High; Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yoram Neuman, MD

  Meir Health Facility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 21, 2015
• Study Start: April 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

IL (1)