Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000676516
Ethics application status
Approved
Date submitted
17/06/2015
Date registered
30/06/2015
Date last updated
7/06/2023
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] 286921 0
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 295345 0
Condition category
Condition code
Cardiovascular 295610 295610 0 0
Coronary heart disease
Human Genetics and Inherited Disorders 295611 295611 0 0
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] 292110 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295326 0
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] 295326 0
1, 3, and 5 years after baseline assessment
Secondary outcome [1] 315360 0
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] 315360 0
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?
No
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
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
2135
Final
Recruitment outside Australia
Country [1] 6981 0
New Zealand
State/province [1] 6981 0

Funding & Sponsors
Funding source category [1] 291479 0
Charities/Societies/Foundations
Name [1] 291479 0
National Heart Foundation of New Zealand
Country [1] 291479 0
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] 290165 0
None
Name [1] 290165 0
Address [1] 290165 0
Country [1] 290165 0
Other collaborator category [1] 278499 0
University
Name [1] 278499 0
The Christchurch Heart Institute, The University of Otago, Christchurch
Address [1] 278499 0
Christchurch Heart Institute
Department of Medicine
University of Otago, Christchurch
P.O. Box 4345
Christchurch 8140
New Zealand
Country [1] 278499 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293026 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 293026 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 293026 0
New Zealand
Date submitted for ethics approval [1] 293026 0
Approval date [1] 293026 0
14/04/2015
Ethics approval number [1] 293026 0

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 58134 0
Prof Rob Doughty
Address 58134 0
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country 58134 0
New Zealand
Phone 58134 0
+64 9 9239804
Fax 58134 0
Email 58134 0
[email protected]
Contact person for public queries
Name 58135 0
A/Prof Malcolm Legget
Address 58135 0
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country 58135 0
New Zealand
Phone 58135 0
+64 9 923 6713
Fax 58135 0
Email 58135 0
[email protected]
Contact person for scientific queries
Name 58136 0
A/Prof Malcolm Legget
Address 58136 0
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country 58136 0
New Zealand
Phone 58136 0
+64 9 923 6713
Fax 58136 0
Email 58136 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?

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
SourceTitleYear of PublicationDOI
EmbasePrognostic modelling of clinical outcomes after first-time acute coronary syndrome in New Zealand.2023https://dx.doi.org/10.1136/heartjnl-2022-322010
EmbaseThe multi-ethnic new zealand study of acute coronary syndromes (Menzacs): Design and methodology.2021https://dx.doi.org/10.3390/cardiogenetics11020010
N.B. These documents automatically identified may not have been verified by the study sponsor.