ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12615000676516

Ethics application status

Approved

Date submitted

17/06/2015

Date registered

30/06/2015

Date last updated

3/08/2024

Date data sharing statement initially provided

16/04/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Multi-Ethnic New Zealand Study of Acute Coronary Syndromes

Scientific title

Genetic and environmental factors contributing to acute coronary syndrome in New Zealand

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1171-2389

Trial acronym

MENZACS

Linked study record

Health condition

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

Acute coronary syndrome

Condition category

Condition code

Cardiovascular

Coronary heart disease

Human Genetics and Inherited Disorders

Other human genetics and inherited disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This study will be a cohort study of 3000 patients admitted to hospital with first time acute coronary syndrome (ACS).

The protocol consists of a baseline visit during admission where clinical and dietary information will be collected along with a blood sample for genomic and biomarker analysis. Subsequent hospital admissions and mortality will be followed for up to 5 years.

Intervention code [1]

Not applicable

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Primary composite endpoint of death, recurrent ACS, revascularisation, and readmission for a cardiac cause.

This is assessed via linkage of data with the All NZ Acute Coronary Syndrome Quality Improvement (ANZACS-QI) database (which will include outcomes) via encrypted patient national health identifier number.

Timepoint [1]

1, 3, and 5 years after baseline assessment

Secondary outcome [1]

Whole-genome array-based genotyping will be performed on the DNA samples of participants to search for genetic variants affecting the risk of acute coronary syndromes.

Timepoint [1]

3 years after baseline assessment

Eligibility

Key inclusion criteria

For cases - patients who are admitted to hospital with first time acute coronary syndrome.
Either
a) Myocardial infarction type 1 according to the Third Universal definition of myocardial infarction
or
b) Unstable angina

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Elevation of troponin and/or ECG changes not thought to be due to an ACS
2. End stage renal failure (eGFR<15 ml/min/m2) OR is receiving OR planned to receive renal replacement therapy
3. Patient is not resident in New Zealand

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Case control

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/07/2015

Actual

30/06/2015

Date of last participant enrolment

Anticipated

30/09/2024

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

3000

Accrual to date

2200

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

National Heart Foundation of New Zealand

Address [1]

PO Box 17-160
Greenlane
Auckland 1546

Country [1]

New Zealand

Primary sponsor type

University

Name

The University of Auckland

Address

The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

The Christchurch Heart Institute, The University of Otago, Christchurch

Address [1]

Christchurch Heart Institute
Department of Medicine
University of Otago, Christchurch
P.O. Box 4345
Christchurch 8140
New Zealand

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington  6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

14/04/2015

Ethics approval number [1]

Summary

Brief summary

This study will be a large scale, multicentre
longitudinal casecontrol study with a long term follow up through the All NZ Acute Coronary Syndrome Quality
Improvement (ANZACSQI) database. The aim is to determine how the genomic and envinronmental risk profiles differ according to ethnicity, age and gender. 

Patients with first time Acute Coronary Syndrome (ACS) will be eligible. A control population will be enrolled through collaboration with primary health care organisations. This will identify an age, gender and ethnicity matched population with no history of coronary disease or surgery. 
We hypothesise that:
a) Genomic profiles of patients presenting with acute coronary syndromes will differ depending on ethnicity and age of onset of disease
b) Different risk alleles will be identified in different ethnic groups and in younger individuals that will yield insights into underlying pathophysiology, and phenotypic differences in disease expression and progression
c) Prognostic variables will be identified from genomic and biomarker analysis that will be able to be incorporated into risk prediction models for outcome

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Rob Doughty

Address

Faculty of Medical and Health Sciences
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand

Country

New Zealand

Phone

+64 9 9239804

Fax

r.doughty@auckland.ac.nz

Contact person for public queries

Name

Malcolm Legget

Address

Faculty of Medical and Health Sciences
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand

Country

New Zealand

Phone

+64 9 923 6713

Fax

malcolml@heartgroup.co.nz

Contact person for scientific queries

Name

Malcolm Legget

Address

Faculty of Medical and Health Sciences
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand

Country

New Zealand

Phone

+64 9 923 6713

Fax

malcolml@heartgroup.co.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The multi-ethnic new zealand study of acute coronary syndromes (Menzacs): Design and methodology.	2021	https://dx.doi.org/10.3390/cardiogenetics11020010
Embase	Prognostic modelling of clinical outcomes after first-time acute coronary syndrome in New Zealand.	2023	https://dx.doi.org/10.1136/heartjnl-2022-322010

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically