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

NCT00507312 | Terminated Phase 1

• 1 other identifier: CP-03/06
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases

Keywords

To assess two new diagnostic devices for detecting early Heart Failure.

Outcome Measures

Primary Outcomes (1)

• To validate the diagnostic ability of the two devices against echo and clinical data as the "gold standard".

  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 Outcomes (1)

• Correlation of the devices with standard tests such as BP, HR and BNP.

  Day 1 (study day)

Study Arms (3)

1

ACTIVE COMPARATOR

Healthy subjects (with no evidence of cardiovascular disease).

Device: HD medical device (ViScope); Device: CSIRO device

2

EXPERIMENTAL

Patients with risk factors for heart failure

Device: HD medical device (ViScope); Device: CSIRO device

3

EXPERIMENTAL

Patients with heart failure

Device: HD medical device (ViScope); Device: CSIRO device

Interventions

HD medical device (ViScope) DEVICE

Device

1; 2; 3

CSIRO device DEVICE

device

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Health patients (must not have any of the following):
• Cardiovascular disease
• Receiving cardiovascular medication
• Not in normal sinus rhythm (also required for HF patients)

Sponsors & Collaborators

• Prof Henry Krum: lead
• HD Medical Group Ltd: collaborator

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Henry Krum, Professor

  Monash University / Alfred Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 26, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2010
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

AU (1)