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Non Invasive Measurement of Cardiac Index by Impedance Cardiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01607515
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : September 9, 2015
Information provided by (Responsible Party):
Medical University of Graz

April 13, 2012
May 30, 2012
September 9, 2015
March 2012
June 2015   (Final data collection date for primary outcome measure)
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
Comparison of CI measured by thermodilution (RHC) and ICG [ Time Frame: 1.5 years ]
Complete list of historical versions of study NCT01607515 on Archive Site
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Non Invasive Measurement of Cardiac Index by Impedance Cardiography
Non Invasive Measurement of Cardiac Index by Impedance Cardiography

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.

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.
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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Pulmonary Hypertension
Other: Impedance cardiography
noninvasive measure of cardiac index by impedance cardiography.
Other Name: patients with a clinical suspicion of PH
suspected PH
Patients who undergo right heart catheterization for PH diagnosis undergo impedance cardiography
Intervention: Other: Impedance cardiography
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2015
June 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
24-205 ex 11/12
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Medical University of Graz
Medical University of Graz
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Principal Investigator: Horst Olschewski, MD Medical University of Graz
Medical University of Graz
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP