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Non Invasive Measurement of Cardiac Index by Impedance Cardiography

Primary Purpose

Pulmonary Hypertension

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Impedance cardiography

About this trial

This is an interventional diagnostic trial for Pulmonary Hypertension focused on measuring Pulmonary hypertension, Cardiac index, impedance cardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients who have right heart catheterization written informed consent

Exclusion Criteria:

patients who don't have right heart catheterization no written informed consent

Sites / Locations

Medical University of Graz

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

suspected PH

Arm Description

Patients who undergo right heart catheterization for PH diagnosis undergo impedance cardiography

Outcomes

Primary Outcome Measures

Comparison of CI measured by ICG and Thermodilution

assessment of the Specificity and sensitivity of ICG for CI measurement

Secondary Outcome Measures

Full Information

NCT ID

NCT01607515

First Posted

April 13, 2012

Last Updated

September 7, 2015

Sponsor

Medical University of Graz

1. Study Identification

Unique Protocol Identification Number

NCT01607515

Brief Title

Non Invasive Measurement of Cardiac Index by Impedance Cardiography

Official Title

Non Invasive Measurement of Cardiac Index by Impedance Cardiography

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Graz

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25 mmHg in the right heart catheterization. There are different forms of PH defined in the classification of Dana Point 2008. PH is diagnosed with right heart catheterization but there are other non invasive methods which can be used for screening like echocardiography, stress echocardiography and cardio pulmonary exercise testing. For prognosis of PH patients the limitation of the pulmonary circulation is very important. Therefore the cardiac index (CI) is a good parameter for the right ventricular function. The gold standard for CI measures is the thermodilution, an invasive method performed during right heart catheterization.

Detailed Description

In this study the investigators want to evaluate the impedance cardiography (ICG) as a non invasive method for CI measurement. An alternating current of max 400µA and 45 kHz is conducted through the body. The way of the smallest resistance is the blood in the aorta. The impedance changes with the pulsatile blood flow. Out of the Impedance change there can be calculated the CI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Hypertension

Keywords

Pulmonary hypertension, Cardiac index, impedance cardiography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

89 (Actual)

8. Arms, Groups, and Interventions

Arm Title

suspected PH

Arm Type

Other

Arm Description

Patients who undergo right heart catheterization for PH diagnosis undergo impedance cardiography

Intervention Type

Other

Intervention Name(s)

Impedance cardiography

Other Intervention Name(s)

patients with a clinical suspicion of PH

Intervention Description

noninvasive measure of cardiac index by impedance cardiography.

Primary Outcome Measure Information:

Title

Comparison of CI measured by ICG and Thermodilution

Description

assessment of the Specificity and sensitivity of ICG for CI measurement

Time Frame

recruitment over 1.5 year (Data collection), followed by data analysis and interpretation (overall 2 yearsfrom start of recruitment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients who have right heart catheterization written informed consent Exclusion Criteria: patients who don't have right heart catheterization no written informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Horst Olschewski, MD

Organizational Affiliation

Medical University of Graz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Graz

City

Graz

ZIP/Postal Code

8036

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

Non Invasive Measurement of Cardiac Index by Impedance Cardiography

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