Non Invasive Measurement of Cardiac Index by Impedance Cardiography

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 3, 2014
Last verified: April 2014
  Purpose

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 Intervention
Pulmonary Hypertension
Other: Impedance cardiography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Non Invasive Measurement of Cardiac Index by Impedance Cardiography

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 73
Study Start Date: March 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607515

Contacts
Contact: Horst Olschewski, MD +43 316 385 12183 horst.olschewski@medunigraz.at
Contact: Maria Tscherner, MD +43 316 385 12183 m.tscherner@medunigraz.at

Locations
Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Horst Olschewski, MD    +43 316 385 12183    horst.olschewski@medunigraz.at   
Contact: Maria Tscherner, MD    +43 316 385 12183    m.tscherner@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Horst Olschewski, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01607515     History of Changes
Other Study ID Numbers: 24-205 ex 11/12
Study First Received: April 13, 2012
Last Updated: April 3, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

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

ClinicalTrials.gov processed this record on August 28, 2014