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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