ANZCTR - Registration

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

Please note that the ANZCTR will be unattended from Friday 18th April until Tuesday 22nd April due to the Easter long weekend. Submissions and updates will not be processed during that time.

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.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
Return to the Login page and enter your new password. A verification code will be sent to your email.
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 registered on ANZCTR

Registration number

ACTRN12625000034437

Ethics application status

Approved

Date submitted

10/07/2024

Date registered

16/01/2025

Date last updated

16/01/2025

Date data sharing statement initially provided

16/01/2025

Type of registration

Retrospectively registered

Titles & IDs

Public title

Circulating macromolecules for non-invasive assessment of heart function

Scientific title

Circulating microRNAs as prognostic markers of ischemic heart disease in adults aged 20-80 years old

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

ischemic heart disease

Condition category

Condition code

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

The study was designed to measure the changes in the expression level of circulating microRNAs with the progression of ischemic heart disease (IHD) and to correlate its expression levels with cardiac function. For this reason, participants who were newly diagnosed with IHD were recruited. Following informed consent and general health questionnaire which is expected to take 15 minutes to complete, blood samples were collected and echocardiography was performed to measure cardiac function. Participants were re-invited at 6, 12, 24, 36, 48 and 60 months for collection of blood samples and echocardiography measurement.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group as this is the timeline study.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Changes in circulating microRNA at different time points with the duration of the disease

Timepoint [1]

Baseline, 6, 12, 24, 36, 48 and 60 months post diagnosis

Primary outcome [2]

Changes in cardiac function at different time points with the duration of the disease

Timepoint [2]

Baseline, 6, 12, 24, 36, 48 and 60 months post diagnosis

Secondary outcome [1]

Nil

Timepoint [1]

Nil

Eligibility

Key inclusion criteria

1. Diabetic or non-diabetic newly diagnosed with ischemic heart disease.
2. Age 20 – 80 years of both genders

Minimum age

20 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. History of acute myocardial infarction
2. History of valvular disease.
3. Aged >80 years and < 20 years
4. Recent major surgery
5. Diagnosed with cancer

Study design

Purpose

Duration

Selection

Timing

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

21/07/2014

Date of last participant enrolment

Anticipated

Actual

17/07/2018

Date of last data collection

Anticipated

Actual

31/08/2022

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Lottery Health New Zealand

Address [1]

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Otago Medical Research Foundation

Address [2]

Country [2]

New Zealand

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Otago Charitable Trust

Address [3]

Country [3]

New Zealand

Funding source category [4]

Charities/Societies/Foundations

Name [4]

Southland Medical Foundation

Address [4]

Country [4]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee (Health)

Ethics committee address [1]

https://www.otago.ac.nz/council/committees/committees/humanethicscommittees

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

04/02/2014

Approval date [1]

15/04/2014

Ethics approval number [1]

H14/28

Summary

Brief summary

Chronic ischemic heart disease (IHD) is a major health issue in many developed countries, including New Zealand, where one in 20 adults has heart disease. Thanks to better treatments, more people are living with chronic IHD. However, it's still hard to predict when their condition might suddenly get worse. While advanced tests can help monitor the disease, they are expensive and require visits to specialized centers. Therefore, we need a simpler and more accessible way to check heart health. MicroRNAs (miRNAs), small molecules in the blood, show promise as they are stable and linked to heart disease. This study aimed to find out if changes in miRNA levels can indicate heart function and help predict disease progression and treatment outcomes in IHD patients.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Rajesh Katare

Address

270 Great King Street, Department of Physiology, University of Otago, 270, Great King Street, Dunedin, Otago, 9010

Country

New Zealand

Phone

+64 212797292

Fax

[email protected]

Contact person for public queries

Name

Rajesh Katare

Address

270 Great King Street, Department of Physiology, University of Otago, 270, Great King Street, Dunedin, Otago, 9010

Country

New Zealand

Phone

+64 212797292

Fax

[email protected]

Contact person for scientific queries

Name

Rajesh Katare

Address

270 Great King Street, Department of Physiology, University of Otago, 270, Great King Street, Dunedin, Otago, 9010

Country

New Zealand

Phone

+64 212797292

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23980	Other	2014			Health Research South Approval for the study	DHB conditional approval for prognostic marker.pdf
23981	Study protocol	2014			Study Protocol	Study Protocol H14_28.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically