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Suspended while we determine if usable data can be collected from this device.
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| Name | Class |
|---|---|
| HD Medical Group Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Healthy subjects (with no evidence of cardiovascular disease). |
|
| 2 | Experimental | Patients with risk factors for heart failure |
|
| 3 | Experimental | Patients with heart failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HD medical device (ViScope) | Device | Device |
| |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of the devices with standard tests such as BP, HR and BNP. |
|
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Inclusion Criteria:
Risk factor patients also require:
Heart Failure patients also require:
Exclusion Criteria:
Health patients (must not have any of the following):
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| Name | Affiliation | Role |
|---|---|---|
| Henry Krum, Professor | Monash University / Alfred Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| CSIRO device |
| Device |
device |
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| Day 1 (study day) |