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3-dimensional Sensor Technology to Quantify Leg-edema

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Medical University of Graz.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01700023
First Posted: October 4, 2012
Last Update Posted: October 4, 2012
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.
Collaborator:
AIT Austrian Institute of Technology GmbH
Information provided by (Responsible Party):
Medical University of Graz
September 30, 2012
October 4, 2012
October 4, 2012
September 2012
December 2012   (Final data collection date for primary outcome measure)
accuracy of 3-dimensional measurements [ Time Frame: 10 days ]
the 3-D camera will record changes in leg-shape around the ankles that result from reabsorption of fluid. These changes will be compared with changes in leg-circumference using a measuring tape
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
3-dimensional Sensor Technology to Quantify Leg-edema
Pilot-study HI-SENS: Innovative Sensor Technology to Quantify Cardiac Control Mechanisms in Heart Failure

The purpose of the study is two-fold:

  1. to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute heart failure with leg-edema.
  2. to measure changes in QRS-morphology in a simulation of conventional blood-pressure measurement in patients hospitalized for acute heart failure.

Leg-edema are common in patients with worsening heart failure. Apart from using a measuring tape there is no standardized tool to quantify leg-edema. Consequently, in patents with heart failure early detection of leg-edema is quite difficult.

From earlier pacemaker-studies it has been shown that an increase of afterload changes ECG-signals. Currently it is unknown how simple diagnostic procedures such as measuring blood-pressure affect QRS-morphology in patients with heart failure.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
patients hospitalized for decompensated heart failure with leg-edema
ADHF
Not Provided
patients with leg-edema
patients with decompensated heart failure presenting with leg-edema
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
15
March 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • hospitalization for worsening heart failure
  • age greater than 18 years
  • ability to stand without help from others
  • informed consent

Exclusion Criteria:

  • leg-edema of non-cardiac origin (venous, lymphatic)
  • dialysis shunt
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT01700023
24-536 ex 11/12
No
Not Provided
Not Provided
Medical University of Graz
Medical University of Graz
AIT Austrian Institute of Technology GmbH
Principal Investigator: Friedrich M Fruhwald, MD Medical University of Graz
Medical University of Graz
October 2012
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