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Non Invasive Measurement of Cardiac Index by Impedance Cardiography

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ClinicalTrials.gov Identifier: NCT01607515
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

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.


Condition or disease Intervention/treatment
Pulmonary Hypertension Other: Impedance cardiography

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non Invasive Measurement of Cardiac Index by Impedance Cardiography
Study Start Date : March 2012
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
suspected PH
Patients who undergo right heart catheterization for PH diagnosis undergo impedance cardiography
Other: Impedance cardiography
noninvasive measure of cardiac index by impedance cardiography.
Other Name: patients with a clinical suspicion of PH



Primary Outcome Measures :
  1. Comparison of CI measured by ICG and Thermodilution [ Time Frame: recruitment over 1.5 year (Data collection), followed by data analysis and interpretation (overall 2 yearsfrom start of recruitment) ]
    assessment of the Specificity and sensitivity of ICG for CI measurement



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01607515


Locations
Austria
Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Horst Olschewski, MD Medical University of Graz

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01607515     History of Changes
Other Study ID Numbers: 24-205 ex 11/12
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by Medical University of Graz:
Pulmonary hypertension
Cardiac index
impedance cardiography

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases