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

NCT ID: NCT00507312

Last Updated: 2015-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Healthy subjects (with no evidence of cardiovascular disease).

Group Type ACTIVE_COMPARATOR

HD medical device (ViScope)

Intervention Type DEVICE

Device

CSIRO device

Intervention Type DEVICE

device

2

Patients with risk factors for heart failure

Group Type EXPERIMENTAL

HD medical device (ViScope)

Intervention Type DEVICE

Device

CSIRO device

Intervention Type DEVICE

device

3

Patients with heart failure

Group Type EXPERIMENTAL

HD medical device (ViScope)

Intervention Type DEVICE

Device

CSIRO device

Intervention Type DEVICE

device

Interventions

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HD medical device (ViScope)

Device

Intervention Type DEVICE

CSIRO device

device

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HD Medical Group Ltd

UNKNOWN

Sponsor Role collaborator

Prof Henry Krum

OTHER

Sponsor Role lead

Responsible Party

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Prof Henry Krum

Prof

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Henry Krum, Professor

Role: PRINCIPAL_INVESTIGATOR

Monash University / Alfred Hospital

Locations

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Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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CP-03/06

Identifier Type: -

Identifier Source: org_study_id

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