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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] 312495 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ischemic heart disease 334355 0
Condition category
Condition code
Cardiovascular 331000 331000 0 0
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] 329014 0
Not applicable
Comparator / control treatment
No control group as this is the timeline study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338766 0
Changes in circulating microRNA at different time points with the duration of the disease
Timepoint [1] 338766 0
Baseline, 6, 12, 24, 36, 48 and 60 months post diagnosis
Primary outcome [2] 340277 0
Changes in cardiac function at different time points with the duration of the disease
Timepoint [2] 340277 0
Baseline, 6, 12, 24, 36, 48 and 60 months post diagnosis
Secondary outcome [1] 443579 0
Nil
Timepoint [1] 443579 0
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?
No
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
60
Accrual to date
Final
54
Recruitment outside Australia
Country [1] 26413 0
New Zealand
State/province [1] 26413 0
Otago

Funding & Sponsors
Funding source category [1] 316915 0
Charities/Societies/Foundations
Name [1] 316915 0
Lottery Health New Zealand
Country [1] 316915 0
New Zealand
Funding source category [2] 316916 0
Charities/Societies/Foundations
Name [2] 316916 0
Otago Medical Research Foundation
Country [2] 316916 0
New Zealand
Funding source category [3] 316917 0
Charities/Societies/Foundations
Name [3] 316917 0
Otago Charitable Trust
Country [3] 316917 0
New Zealand
Funding source category [4] 316918 0
Charities/Societies/Foundations
Name [4] 316918 0
Southland Medical Foundation
Country [4] 316918 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 319163 0
None
Name [1] 319163 0
Address [1] 319163 0
Country [1] 319163 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315673 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 315673 0
https://www.otago.ac.nz/council/committees/committees/humanethicscommittees
Ethics committee country [1] 315673 0
New Zealand
Date submitted for ethics approval [1] 315673 0
04/02/2014
Approval date [1] 315673 0
15/04/2014
Ethics approval number [1] 315673 0
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 135458 0
A/Prof Rajesh Katare
Address 135458 0
270 Great King Street, Department of Physiology, University of Otago, 270, Great King Street, Dunedin, Otago, 9010
Country 135458 0
New Zealand
Phone 135458 0
+64 212797292
Fax 135458 0
Email 135458 0
[email protected]
Contact person for public queries
Name 135459 0
Rajesh Katare
Address 135459 0
270 Great King Street, Department of Physiology, University of Otago, 270, Great King Street, Dunedin, Otago, 9010
Country 135459 0
New Zealand
Phone 135459 0
+64 212797292
Fax 135459 0
Email 135459 0
[email protected]
Contact person for scientific queries
Name 135460 0
Rajesh Katare
Address 135460 0
270 Great King Street, Department of Physiology, University of Otago, 270, Great King Street, Dunedin, Otago, 9010
Country 135460 0
New Zealand
Phone 135460 0
+64 212797292
Fax 135460 0
Email 135460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




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.