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

Primary Purpose

Cardiovascular Diseases

Status
Terminated
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
HD medical device (ViScope)
CSIRO device
Sponsored by
Prof Henry Krum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiovascular Diseases focused on measuring To assess two new diagnostic devices for detecting early Heart Failure.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Alfred Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Healthy subjects (with no evidence of cardiovascular disease).

Patients with risk factors for heart failure

Patients with heart failure

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2007
Last Updated
June 2, 2015
Sponsor
Prof Henry Krum
Collaborators
HD Medical Group Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00507312
Brief Title
Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools
Official Title
Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Suspended while we determine if usable data can be collected from this device.
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof Henry Krum
Collaborators
HD Medical Group Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
To assess two new diagnostic devices for detecting early Heart Failure.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Healthy subjects (with no evidence of cardiovascular disease).
Arm Title
2
Arm Type
Experimental
Arm Description
Patients with risk factors for heart failure
Arm Title
3
Arm Type
Experimental
Arm Description
Patients with heart failure
Intervention Type
Device
Intervention Name(s)
HD medical device (ViScope)
Intervention Description
Device
Intervention Type
Device
Intervention Name(s)
CSIRO device
Intervention Description
device
Primary Outcome Measure Information:
Title
To validate the diagnostic ability of the two devices against echo and clinical data as the "gold standard".
Description
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".
Time Frame
Day 1 (study day)
Secondary Outcome Measure Information:
Title
Correlation of the devices with standard tests such as BP, HR and BNP.
Description
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.
Time Frame
Day 1 (study day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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): Cardiovascular disease Receiving cardiovascular medication Not in normal sinus rhythm (also required for HF patients)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Krum, Professor
Organizational Affiliation
Monash University / Alfred Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

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

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