Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools

June 2, 2015 updated by: Prof Henry Krum

This study will be testing two devices which are designed to detect cardiovascular disease in patients as early as possible. As there are now many therapies to prevent and treat this condition it is believed that detecting it early will help reduce the burden of the disease and permit more effective treatment.

The two devices the investigators are testing are the ViScope developed by HD Medical and a device developed by CSIRO. Both of these devices are simple, non-invasive and may provide useful information on how well the heart contracts and relaxes as well as valve function of the heart.

The investigators are planning to enroll 100 healthy subjects, 100 participants with risk factors for heart failure and 300 patients with varying types of heart failure.

The data collected from the experimental devices will be compared to the results from standard tests.

Patients will not have any of their therapies altered as part of this study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 18 years
  • Have provided consent

Risk factor patients also require:

  • Hypertension > 2 years
  • Diabetes > 2 years
  • Known ischemia, TIA, or stroke
  • Arrhythmia; or reduced renal function (eGFR<50 ml/min)

Heart Failure patients also require:

  • LVEF <40%
  • Receiving standard medication for the treatment of symptomatic systolic heart failure with an NYHA Class of II-IV.

Exclusion Criteria:

Health patients (must not have any of the following):

  1. Cardiovascular disease
  2. Receiving cardiovascular medication
  3. Not in normal sinus rhythm (also required for HF patients)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Healthy subjects (with no evidence of cardiovascular disease).
Device: HD medical device (ViScope)
Device
Device: CSIRO device
device
Experimental: 2
Patients with risk factors for heart failure
Device: HD medical device (ViScope)
Device
Device: CSIRO device
device
Experimental: 3
Patients with heart failure
Device: HD medical device (ViScope)
Device
Device: CSIRO device
device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To validate the diagnostic ability of the two devices against echo and clinical data as the "gold standard".
Time Frame: Day 1 (study day)
We will construct received operative characteristic (Roc) curves for sensitivity and specificity of the HD Medical ViScope and the CSIRO back scatter analysis device in detecting heart failure using echocardiogram and clinical data as the "gold standard".
Day 1 (study day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of the devices with standard tests such as BP, HR and BNP.
Time Frame: Day 1 (study day)
  • Correlation of device values with echocardiogram parameters of systolic and diastolic function.
  • Correlation of device values with BNP levels.
  • Correlation of device values with heart rate variability measurements.
  • Correlation of device values with pulse wave velocity and systemic arterial compliance assessment measures.
Day 1 (study day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof Henry Krum

Collaborators

HD Medical Group Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 25, 2007

First Submitted That Met QC Criteria

July 25, 2007

First Posted (Estimate)

July 26, 2007

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-03/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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