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| Sponsors and Collaborators: |
Monash University HD Medical Group Limited |
|---|---|
| Information provided by: | Monash University |
| ClinicalTrials.gov Identifier: | NCT00507312 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Diseases |
Device: HD medical device (ViScope) Device: CSIRO device |
Phase I |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Assessment of Myocardial Disease in Man Using Novel Non-Invasive Diagnostic Tools |
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Health subjects (with no evidence of cardiovascular disease).
|
Device: HD medical device (ViScope)
Device
Device: CSIRO device
device
|
|
2: Experimental
Patients with risk factors for heart failure
|
Device: HD medical device (ViScope)
Device
Device: CSIRO device
device
|
|
3: Experimental
Patients with heart failure
|
Device: HD medical device (ViScope)
Device
Device: CSIRO device
device
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Risk factor patients also require:
Heart Failure patients also require:
Exclusion Criteria:
Health patients (must not have any of the following):
Contacts and Locations| Contact: Henry Krum, Professor | +61 3 9903 0042 | henry.krum@med.monash.edu.au |
| Australia, Victoria | |
| Alfred Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: Henry Krum, Professor +61 3 9903 0042 henry.krum@med.monash.edu.au | |
| Principal Investigator: Henry Krum, Professor | |
| Principal Investigator: | Henry Krum, Professor | Monash University / Alfred Hospital |
More Information
| Responsible Party: | HD Medical Group Limited ( Jay Jethwa ) |
| Study ID Numbers: | CP-03/06 |
| Study First Received: | July 25, 2007 |
| Last Updated: | October 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00507312 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
To assess two new diagnostic devices for detecting early Heart Failure. |
|
Heart Failure Heart Diseases Cardiomyopathies |
|
Cardiovascular Diseases |
