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Non Invasive Measurement of Cardiac Index by Impedance Cardiography

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01607515
First received: April 13, 2012
Last updated: November 23, 2014
Last verified: November 2014

April 13, 2012
November 23, 2014
March 2012
July 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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01607515 on ClinicalTrials.gov 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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
73
July 2015
July 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
Both
18 Years and older
No
Contact: Horst Olschewski, MD +43 316 385 12183 horst.olschewski@medunigraz.at
Contact: Maria Tscherner, MD +43 316 385 12183 m.tscherner@medunigraz.at
Austria
 
NCT01607515
24-205 ex 11/12
No
Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Horst Olschewski, MD Medical University of Graz
Medical University of Graz
November 2014

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