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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00507312




Registration number
NCT00507312
Ethics application status
Date submitted
25/07/2007
Date registered
26/07/2007
Date last updated
4/06/2015

Titles & IDs
Public title
Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools
Scientific title
Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools
Secondary ID [1] 0 0
CP-03/06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - HD medical device (ViScope)
Treatment: Devices - CSIRO device

Active Comparator: 1 - Healthy subjects (with no evidence of cardiovascular disease).

Experimental: 2 - Patients with risk factors for heart failure

Experimental: 3 - Patients with heart failure


Treatment: Devices: HD medical device (ViScope)
Device

Treatment: Devices: CSIRO device
device

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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".
Timepoint [1] 0 0
Day 1 (study day)
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 1 (study day)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Health patients (must not have any of the following):

1. Cardiovascular disease

2. Receiving cardiovascular medication

3. Not in normal sinus rhythm (also required for HF patients)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Prof Henry Krum
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
HD Medical Group Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.

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.
Trial website
https://clinicaltrials.gov/show/NCT00507312
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Krum, Professor
Address 0 0
Monash University / Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00507312