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

Phase 1

Terminated

• Conditions: Cardiovascular Diseases
• Interventions: Device: HD medical device (ViScope); Device: CSIRO device

• Registration Number: NCT00507312
• Lead Sponsor: Prof Henry Krum

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-25
• Study First Submitted QC: 2007-07-25
• Study First Posted: 2007-07-26
• Study Start: 2007-10
• Primary Completion: 2009-01
• Study Completion: 2010-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CSIRO device	Healthy subjects (with no evidence of cardiovascular disease).
2	HD medical device (ViScope)	Patients with risk factors for heart failure
3	CSIRO device	Patients with heart failure
1	HD medical device (ViScope)	Healthy subjects (with no evidence of cardiovascular disease).
2	CSIRO device	Patients with risk factors for heart failure
3	HD medical device (ViScope)	Patients with heart failure

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia