3-dimensional Sensor Technology to Quantify Leg-edema | NCT01700023

Studies
3-dimensional Sensor Technology to Quantify Leg-edema

NCT01700023

Sponsor

Medical University of Graz

Status

Unknown status

Last Update Posted

Oct 4, 2012Estimated

Enrollment

15Estimated

Phase

Not provided

Conditions

ADHF

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Sep 30, 2012

First Submission Date that Met QC Criteria

Oct 3, 2012

First Posted Date

Oct 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2012

Last Update Posted Date

Oct 4, 2012Estimated

Name	Class
AIT Austrian Institute of Technology GmbH	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is two-fold:

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

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with leg-edema		patients with decompensated heart failure presenting with leg-edema

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
accuracy of 3-dimensional measurements	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	10 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients hospitalized for decompensated heart failure with leg-edema

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Friedrich M Fruhwald, MD	Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University	Recruiting	Graz		8036	Austria

Type	Date	Date Unknown
Release	Oct 28, 2013
Reset	Dec 17, 2013
Release	Jun 11, 2014
Reset	Jul 11, 2014
Release	Oct 2, 2015
Reset	Nov 3, 2015

Submission Tracking

Estimated Results First Submitted Date

Oct 28, 2013

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 28, 2013			Dec 17, 2013
Jun 11, 2014