Cardiovascular DiseasesPhase 1NCT00507312
Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools
A Phase 1 study testing HD medical device (ViScope) and CSIRO device in people with Cardiovascular Diseases, run by Prof Henry Krum at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- HD medical device (ViScope) and CSIRO device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2007to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years
- Have provided consent
- Risk factor patients also require:
- Hypertension > 2 years
- Diabetes > 2 years
- Known ischemia, TIA, or stroke
Show all 10Show fewer
- 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.
Who cannot join
- Health patients (must not have any of the following):
- Cardiovascular disease
- Receiving cardiovascular medication
- Not in normal sinus rhythm (also required for HF patients)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- HD medical device (ViScope), CSIRO device
- Keywords
- To assess two new diagnostic devices for detecting early Heart Failure.
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD medical device (ViScope)Device
Device
CSIRO deviceDevice
device
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Healthy subjects (with no evidence of cardiovascular disease). Receives: Device: HD medical device (ViScope); Device: CSIRO device |
| 2 | Experimental | Patients with risk factors for heart failure Receives: Device: HD medical device (ViScope); Device: CSIRO device |
| 3 | Experimental | Patients with heart failure Receives: Device: HD medical device (ViScope); Device: CSIRO device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Day 1 (study day)
Secondary outcomes (1)
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.
Measured: Day 1 (study day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2009
- Study completionDec 2010
Why it stopped: Suspended while we determine if usable data can be collected from this device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof Henry Krum
- Sponsor type
- University, hospital or other
- Collaborators
- HD Medical Group Ltd
- Responsible party
- Sponsor-investigator, Prof Henry Krum, Monash University
- Investigators
- Henry Krum, Professor, Principal investigator, Monash University / Alfred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507312
- Sponsor's protocol ID
- CP-03/06
- Status last verified
- Jun 2015
- First submitted
- 25 Jul 2007
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools
- ClinicalTrials.gov ID
- NCT00507312
- Acronym / sponsor ID
- CP-03/06
- Conditions
- Cardiovascular Diseases
- Keywords
- To assess two new diagnostic devices for detecting early Heart Failure.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended while we determine if usable data can be collected from this device.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Prof Henry KrumUniversity, hospital or other
- Collaborators
- HD Medical Group Ltd
- Study start
- Oct 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: HD medical device (ViScope), Device: CSIRO deviceHealthy subjects (with no evidence of cardiovascular disease). |
| 2 | Experimental | Device: HD medical device (ViScope), Device: CSIRO devicePatients with risk factors for heart failure |
| 3 | Experimental | Device: HD medical device (ViScope), Device: CSIRO devicePatients with heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Over 18 years
- Have provided consent
- Hypertension > 2 years
- Diabetes > 2 years
- Known ischemia, TIA, or stroke
Key exclusion criteria (4 listed)
- Cardiovascular disease
- Receiving cardiovascular medication
- Not in normal sinus rhythm (also required for HF patients)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HD medical device (ViScope)Device | Device | 1, 2, 3 |
| CSIRO devicedevice | Device | 1, 2, 3 |
Primary outcome
To validate the diagnostic ability of the two devices against echo and clinical data as the "gold standard".
Time frame: 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".
1 secondary outcome
Correlation of the devices with standard tests such as BP, HR and BNP.
Time frame: Day 1 (study day)
Results and safety
The study was stopped early (reason given: Suspended while we determine if usable data can be collected from this device.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Krum, Professor principal investigator
Monash University / Alfred Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HD medical device (ViScope) and CSIRO device in people with Cardiovascular Diseases, run by Prof Henry Krum at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Suspended while we determine if usable data can be collected from this device.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the diagnostic ability of the two devices against echo and clinical data as the "gold standard". (time frame: Day 1 (study day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.