Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools
NCT ID: NCT00507312
Last Updated: 2015-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
41 participants
INTERVENTIONAL
2007-10-31
2010-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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1
Healthy subjects (with no evidence of cardiovascular disease).
HD medical device (ViScope)
Device
CSIRO device
device
2
Patients with risk factors for heart failure
HD medical device (ViScope)
Device
CSIRO device
device
3
Patients with heart failure
HD medical device (ViScope)
Device
CSIRO device
device
Interventions
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HD medical device (ViScope)
Device
CSIRO device
device
Eligibility Criteria
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Inclusion Criteria
* 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
1. Cardiovascular disease
2. Receiving cardiovascular medication
3. Not in normal sinus rhythm (also required for HF patients)
18 Years
ALL
Yes
Sponsors
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HD Medical Group Ltd
UNKNOWN
Prof Henry Krum
OTHER
Responsible Party
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Prof Henry Krum
Prof
Principal Investigators
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Henry Krum, Professor
Role: PRINCIPAL_INVESTIGATOR
Monash University / Alfred Hospital
Locations
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Alfred Hospital
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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CP-03/06
Identifier Type: -
Identifier Source: org_study_id
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