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3-dimensional Sensor Technology to Quantify Leg-edema

This study is currently recruiting participants.
Verified October 2012 by Medical University of Graz
Sponsor:
Collaborator:
AIT Austrian Institute of Technology
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01700023
First received: September 30, 2012
Last updated: October 3, 2012
Last verified: October 2012
History of Changes

September 30, 2012
October 3, 2012
September 2012
December 2012   (final data collection date for primary outcome measure)
accuracy of 3-dimensional measurements [ Time Frame: 10 days ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01700023 on ClinicalTrials.gov Archive Site
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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
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Non-Probability Sample

patients hospitalized for decompensated heart failure with leg-edema
ADHF
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patients with leg-edema
patients with decompensated heart failure presenting with leg-edema
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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
Both
18 Years and older
No
Not Provided
Austria
 
NCT01700023
24-536 ex 11/12
No
Medical University of Graz
Medical University of Graz
AIT Austrian Institute of Technology
Principal Investigator: Friedrich M Fruhwald, MD Medical University of Graz
Medical University of Graz
October 2012

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