Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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".
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.
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
41
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00507312