Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000431628
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
16/09/2005
Date last updated
22/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Acute Coronary Syndrome Study
Scientific title
Hormones and echo as indicators of diastolic function and outcomes in cardiac disease.
Secondary ID [1] 294381 0
none
Universal Trial Number (UTN)
Trial acronym
The ACS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 541 0
Condition category
Condition code
Cardiovascular 620 620 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None
Intervention code [1] 540 0
None
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 725 0
Establish relationships between plasma concentrations of known and newly discovered candidate marker peptides and established and newly validated echocardiographic indicators of left ventricular diastolic function in patients (with a spectrum of systolic function) surviving admission with an acute coronary syndrome.
Timepoint [1] 725 0
3 years
Secondary outcome [1] 1490 0
Establish relationships of plasma marker peptides to changes in ventricular and systolic structure and function (i.e. remodelling).
Timepoint [1] 1490 0
3 years
Secondary outcome [2] 1491 0
Establish relationships of peptide and echo indicators to clinical outcomes including recurrent ischaemic syndromes, heart failure and mortality.
Timepoint [2] 1491 0
3 years

Eligibility
Key inclusion criteria
Ischaemic discomfort plus one or more of ECG changes (ST segment depression or elevation of at least 0.5mm, T-wave inversion of at least 3mm in at least 3 leads, or left bundle branch block), elevated levels of cardiac markers, a history of coronary disease, or age of at least 65 years in patients with diabetes or vascular disease (i.e. the identical criteria as those used in the recent OPUS-TIMI 16 trial and reiterated in the recent New England Journal article by De Lemos et al on the prognostic value of B-type natriuretic peptide in patients with acute coronary syndromes [43a]). The deliberate aim is to include a broad spectrum of age, both genders and significant sub-groups with the important antecedent risk factors and disease processes such as hypertension and diabetes.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe co-morbidity limiting life expectancy to less than 3 years. Unable to provide written informed consent. Unable to attend for follow-up.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2002
Actual
1/07/2002
Date of last participant enrolment
Anticipated
Actual
12/02/2009
Date of last data collection
Anticipated
Actual
15/03/2018
Sample size
Target
2000
Accrual to date
Final
2203
Recruitment outside Australia
Country [1] 209 0
New Zealand
State/province [1] 209 0

Funding & Sponsors
Funding source category [1] 678 0
Government body
Name [1] 678 0
NZ Health Research Council
Country [1] 678 0
New Zealand
Primary sponsor type
Government body
Name
NZ Health Research Council
Address
PO Box 5541, Wellesley Street, Auckland 1141
Country
New Zealand
Secondary sponsor category [1] 567 0
None
Name [1] 567 0
n/a
Address [1] 567 0
Country [1] 567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1858 0
Chrischurch
Ethics committee address [1] 1858 0
Ethics committee country [1] 1858 0
New Zealand
Date submitted for ethics approval [1] 1858 0
Approval date [1] 1858 0
24/06/2002
Ethics approval number [1] 1858 0
Ethics committee name [2] 1859 0
Auckland
Ethics committee address [2] 1859 0
Ethics committee country [2] 1859 0
New Zealand
Date submitted for ethics approval [2] 1859 0
Approval date [2] 1859 0
Ethics approval number [2] 1859 0

Summary
Brief summary
Measurement of blood levels of hormones produced by the heart in response to stress or injury have been shown to predict the risk of death or deterioration in heart function in patients with heart disease. Recently validated techniques in echocardiography for grading heart function also stand as strong clinical indicators We propose to apply both methods of assessment to a broad range of patients who have all survived a recent crisis from coronary artery disease and are at the point of discharge (or within 8 weeks after discharge) from hospital. Positive results should enable targeting of intensified follow-up and medical treatment aimed at improving outcomes in those demonstrated to be at high risk for later problems
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35749 0
Prof Mark Richards
Address 35749 0
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8041
Country 35749 0
New Zealand
Phone 35749 0
+6433641063
Fax 35749 0
Email 35749 0
mark.richards@cdhb.health.nz
Contact person for public queries
Name 9729 0
Prof Professor Mark Richards
Address 9729 0
Christchurch Cardioendocrine Research Group
Department of Medicine
Christchurch School of Medicine & Health Sciences
University of Otago
PO Box 4345
Christchurch
Country 9729 0
New Zealand
Phone 9729 0
+64 3 3641063
Fax 9729 0
+64 3 3641115
Email 9729 0
mark.richards@cdhb.govt.nz
Contact person for scientific queries
Name 657 0
Ms Lorraine Skelton
Address 657 0
Department of Medicine
Christchurch School of Medicine & Health Sciences
University of Otago
PO Box 4345
Christchurch
Country 657 0
New Zealand
Phone 657 0
+64 3 2641063
Fax 657 0
+64 3 3641115
Email 657 0
lorraine.skelton@cdhb.govt.nz

No information has been provided regarding IPD availability


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
EmbaseCirculating miR-323-3p and miR-652: Candidate markers for the presence and progression of acute coronary syndromes.2014https://dx.doi.org/10.1016/j.ijcard.2014.07.068
EmbasePlasma levels of soluble VEGF receptor isoforms, circulating pterins and VEGF system SNPs as prognostic biomarkers in patients with acute coronary syndromes.2018https://dx.doi.org/10.1186/s12872-018-0894-1
EmbaseVascular endothelial growth factor-A promoter polymorphisms, circulating VEGF-A and survival in acute coronary syndromes.2021https://dx.doi.org/10.1371/journal.pone.0254206
Dimensions AIConvalescent troponin and cardiovascular death following acute coronary syndrome2019https://doi.org/10.1136/heartjnl-2019-315084
Dimensions AIIdentifying Candidate Circulating RNA Markers for Coronary Artery Disease by Deep RNA-Sequencing in Human Plasma2022https://doi.org/10.3390/cells11203191
Dimensions AIBetaine and Trimethylamine-N-Oxide as Predictors of Cardiovascular Outcomes Show Different Patterns in Diabetes Mellitus: An Observational Study2014https://doi.org/10.1371/journal.pone.0114969
N.B. These documents automatically identified may not have been verified by the study sponsor.