Non-invasive Diagnosis of Pulmonary Hypertension by Impedance Cardiography

November 17, 2020 updated by: Medical University of Graz

Non-invasive Diagnosis of Pulmonary Hypertension by Thoracic Impedance Cardiography - a Prospective Study

The goal of the study is to prospectively evaluate Impedance Cardiography as a tool to detect pulmonary hypertension. According to our hypothesis Impedance Cardiography is a valuable method to differentiate patients without pulmonary hypertension from patients with pulmonary hypertension. The main objective is to determine the sensitivity and specificity in comparison to the gold standard right heart catheterization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Medical University Graz, Division of Pulmonology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of the clinical department of Pulmonology of the Medical University of Graz undergoing right heart catheterization for clinical reasons will be included

Description

Inclusion Criteria:

  • Written Informed Consent
  • Patients with clinical indication for right heart catheterization

Exclusion Criteria:

  • known Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Impedance Cardiography
Diagnostic test: Impedance Cardiography

Impedance Cardiography will be conducted in patients with suspected Pulmonary Hypertension within an interval of 24 hours to right-heart catheterization. Usually, 8 electrodes will be attached on the neck and thorax of the patient. These electrodes will produce current (max 400µA) and measure the voltage which is produced by the current running through the body. The Signal will be analyzed for specific signs of Pulmonary Hypertension.

At the same time electrocardiography and non-invasive continuous blood pressure will be measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of pulmonary hypertension
Time Frame: 1 hour
The sensitivity and specificity of Impedance Cardiography in the diagnosis of pulmonary Hypertension (as compared with the Gold Standard right heart catheterization) will be determined.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2018

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

December 5, 2018

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29-478 ex 16/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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