ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 221 for:    heart disease AND stroke AND California

Calibrating Cardiac Output Measurement of Electrical Cardiometry With Transthoracic Echocardiography (EC vs TTE)

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.
ClinicalTrials.gov Identifier: NCT02702063
Recruitment Status : Unknown
Verified March 2016 by Clemens Ortner, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : March 8, 2016
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Clemens Ortner, Medical University of Vienna

Brief Summary:
Cardiac output (CO) is a key variable when describing the cardiovascular system. Electrical cardiometry (EC) is a non-invasive method in measuring stroke volume and cardiac output. However, its accuracy has been inconsistent. Therefore Martin et al. have compared measurements with echocardiographic measurements and propose calibration with left ventricle outflow tract (LVOT)-measurements obtained from transthoracic echocardiography (TTE). This study was performed in pregnant women at term. Goal of this study is to validate their formula in non-pregnant outpatients undergoing echocardiography for cardiology work-up. Secondary aim is to perform a leg raising test and to compare changes in stroke volume observed with either EC or TTE.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: passive leg raising test Procedure: right heart catheterisation Other: TTE vs. EC + calibration group Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : October 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
TTE vs. EC + calibration group

50 Patients undergoing routine transthoracic echocardiography at laboratory for transthoracic echocardiography at the department of cardiology of Medical University Vienna will be enrolled following informed consent. Non-inclusion criteria are inability to understand study procedure and age under 18 years old.

Patients with any grade of aortic regurgitation, congenital heart disease with intracardiac shunt (left-right shunt or right-left shunt) or arrhythmia (atrial fibrillation) or withdrawing consent during study procedure will be excluded. In addition, patients with intraabdominal (IAH), intracranial (ICH) hypertension or any disease of the hip joint, will not be included into the trial.

Other: TTE vs. EC + calibration group
Patients will undergo routine echocardiography. CO and SV will be measured by TTE and compared to measurements obtained from simultaneous EC-measurements.
Right heart catheterisation
Twenty five patients undergoing routine right heart catheterization (RHC) at the department of cardiology for the evaluation of suspected pulmonary hypertension or heart failure will be included in this trial. EC measurements will be obtained during RHC, and a TTE (for measuring LVOT-area) will be performed immediately before undergoing RHC. Inclusion and exclusion criteria are similar as described above.
Procedure: right heart catheterisation
CO in patients undergoing routine right heart catheterisation will be measured and compared between 3 methodologies: right heart catheterisation, TTE and EC
Passive leg raising test

50 Patients undergoing routine transthoracic echocardiography at laboratory for transthoracic echocardiography at the department of cardiology of Medical University Vienna will be enrolled following informed consent. Non-inclusion criteria are inability to understand study procedure and age under 18 years old.

Patients with any grade of aortic regurgitation, congenital heart disease with intracardiac shunt (left-right shunt or right-left shunt) or arrhythmia (atrial fibrillation) or withdrawing consent during study procedure will be excluded. In addition, patients with intraabdominal (IAH), intracranial (ICH) hypertension or any disease of the hip joint, will not be included into the trial.

SV and CO will be measured using TTE and EC. Patient's legs will then be raised by 45degree, and SV and CO measurements will be repeated after 1 minute. Changes in SV and CO observed with both methods will be compared.

Other: passive leg raising test
Patients undergoing routine echocardiography are exposed to a passive leg raising test. Change in SV will be measured by TTE and compared to changes in SV measured by EC.



Primary Outcome Measures :
  1. agreement Stroke volume [ Time Frame: 3 seconds ]
    SV measured by TTE, RHC and EC will be compared



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • age above 18 years
  • able to understand study procedure

Exclusion Criteria:

  • aortic regurgitation
  • congenital heart disease with intracardiac shunt
  • arrhythmia
  • withdrawing 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): NCT02702063


Contacts
Contact: Clemens M Ortner, MD +434040041009 clemens.ortner@meduniwien.ac.at

Locations
Austria
Medical University Vienna Recruiting
Vienna, Austria, 1080
Contact: Ortner, MD, MSC    0431404004100    clemens.ortner@meduniwien.ac.at   
Sub-Investigator: Clemens Ortner, MD, MSC         
Sponsors and Collaborators
Medical University of Vienna
University of California, San Diego

Responsible Party: Clemens Ortner, Assistant Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02702063     History of Changes
Other Study ID Numbers: MUVienna 1139/2015
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases