Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools

Cardiovascular Diseases Clinical Trial

Official title:

Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00507312
• Other study ID #: CP-03/06
• Status: Terminated
• Phase: Phase 1
• First received: July 25, 2007
• Last updated: June 2, 2015
• Start date: October 2007
• Est. completion date: December 2010

Study information

• Verified date: June 2015
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: December 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiovascular Diseases

Intervention

Device:
• HD medical device (ViScope)
Device
• CSIRO device
device

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Prof Henry Krum	HD Medical Group Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	Day 1 (study day)	No
Secondary	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.	Day 1 (study day)	No