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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: HD medical device (ViScope)
* Device: CSIRO device


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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To assess two new diagnostic devices for detecting early Heart Failure.