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

This study has suspended participant recruitment.
(Suspended while we determine if usable data can be collected from this device.)
Sponsor:
Information provided by:
Monash University
ClinicalTrials.gov Identifier:
NCT00507312
First received: July 25, 2007
Last updated: April 27, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Device: HD medical device (ViScope)
Device: CSIRO device
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools

Resource links provided by NLM:


Further study details as provided by Monash University:

Primary Outcome Measures:
  • To validate the diagnostic ability of the two devices against echo and clinical data as the "gold standard". [ Time Frame: Day 1 (study day) ] [ Designated as safety issue: No ]
    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".


Secondary Outcome Measures:
  • Correlation of the devices with standard tests such as BP, HR and BNP. [ Time Frame: Day 1 (study day) ] [ Designated as safety issue: No ]
    • 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.


Estimated Enrollment: 500
Study Start Date: October 2007
Estimated Study Completion Date: December 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507312

Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Monash University
Investigators
Principal Investigator: Henry Krum, Professor Monash University / Alfred Hospital
  More Information

No publications provided

Responsible Party: Jay Jethwa, HD Medical Group Limited
ClinicalTrials.gov Identifier: NCT00507312     History of Changes
Other Study ID Numbers: CP-03/06
Study First Received: July 25, 2007
Last Updated: April 27, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Monash University:
To assess two new diagnostic devices for detecting early Heart Failure.

Additional relevant MeSH terms:
Cardiovascular Diseases
Cardiomyopathies
Heart Diseases

ClinicalTrials.gov processed this record on August 26, 2014