Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000026820
Ethics application status
Approved
Date submitted
1/10/2020
Date registered
14/01/2021
Date last updated
14/01/2021
Date data sharing statement initially provided
14/01/2021
Date results information initially provided
14/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Relative contribution of trends in cardiovascular disease event rates and case fatality to declines in mortality: an international population-based comparative study
Scientific title
Relative contribution of trends in cardiovascular disease event rates and case fatality to declines in mortality during 2002 to 2015: an international retrospective population-based comparative study
Secondary ID [1] 302383 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 319170 0
Condition category
Condition code
Cardiovascular 317135 317135 0 0
Coronary heart disease
Stroke 317137 317137 0 0
Ischaemic
Stroke 317139 317139 0 0
Haemorrhagic
Public Health 317140 317140 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational.
All people experiencing a cardiovascular disease (CVD) hospitalisation or death between 1st January 2002 and 31st December 2015 in England, New South Wales (Australia), New Zealand, and Ontario (Canada) will be identified. Person-linked administrative health datasets from each jurisdiction will be used for identification of all specified CVD events. Specified CVD events include myocardial infarction, acute stroke, coronary heart disease, cerebrovascular disease, and a grouping for all CVD events.
Intervention code [1] 318680 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325226 0
Cardiovascular disease mortality.
This outcome will be obtained from linked mortality datasets from each jurisdiction. Each dataset contains all CVD deaths from 2002 to 2015 and includes deaths in people hospitalised with CVD and CVD deaths occurring out of hospital.
Timepoint [1] 325226 0
Annual CVD mortality rates.
Annual cardiovascular disease mortality rates from 2002-2015 will be estimated following receipt of full study datasets.
Primary outcome [2] 326138 0
CVD event rates (composite of nonfatal and fatal CVD events).
This outcome will be obtained from linked hospitalisation and mortality datasets from each jurisdiction. Each dataset contains all CVD hospitalisations and deaths from 2002 to 2015 and includes deaths in people hospitalised with CVD and CVD deaths occurring out of hospital.
Timepoint [2] 326138 0
Annual CVD event rates.
Annual cardiovascular disease event rates from 2002-2015 will be estimated following receipt of full study datasets.
Secondary outcome [1] 387273 0
Myocardial infarction mortality.
This outcome will be obtained from linked mortality datasets from each jurisdiction. Each dataset contains all CVD deaths from 2002 to 2015 and includes deaths in people hospitalised with CVD and CVD deaths occurring out of hospital.
Timepoint [1] 387273 0
Annual myocardial infarction mortality rates.
Annual MI mortality rates from 2002-2015 will be estimated following receipt of full study datasets.
Secondary outcome [2] 387274 0
Stroke mortality (composite of ischaemic, haemorrhagic and unspecified stroke subtypes).
This outcome will be obtained from linked mortality datasets from each jurisdiction. Each dataset contains all CVD deaths from 2002 to 2015 and includes deaths in people hospitalised with CVD and CVD deaths occurring out of hospital.
Timepoint [2] 387274 0
Annual stroke mortality rates
Annual stroke mortality rates from 2002-2015 will be estimated following receipt of full study datasets.
Secondary outcome [3] 390226 0
Myocardial infarction event rates (composite of nonfatal and fatal MI events).
This outcome will be obtained from linked hospitalisation and mortality datasets from each jurisdiction. Each dataset contains all CVD hospitalisations and deaths from 2002 to 2015 and includes deaths in people hospitalised with CVD and CVD deaths occurring out of hospital.
Timepoint [3] 390226 0
Annual myocardial infarction event rates.
Annual MI event rates from 2002-2015 will be estimated following receipt of full study datasets.
Secondary outcome [4] 390227 0
Stroke event rates (composite of nonfatal and fatal CVD events).
This outcome will be obtained from linked hospitalisation and mortality datasets from each jurisdiction. Each dataset contains all CVD hospitalisations and deaths from 2002 to 2015 and includes deaths in people hospitalised with CVD and CVD deaths occurring out of hospital.
Timepoint [4] 390227 0
Annual stroke event rates.
Annual stroke event rates from 2002-2015 will be estimated following receipt of full study datasets.

Eligibility
Key inclusion criteria
All hospitalisations and deaths which meet the specific requirements for each condition, based on International Classification of Disease coding, diagnosis or cause of death fields, and time period (admissions and deaths occurring between 01 January 2002 and 31 December 2015).
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Criteria will be imposed which exclude patients with low probability of a major cardiovascular event, such as short length of stay and elective admissions for acute events such as myocardial infarction or stroke.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Event rates and case fatality for each cardiovascular condition will be age-standardised using the direct method. Temporal trends for each will be calculated using appropriate age-adjusted regression models. Effects of differing inputs on mortality trends will be analysed, and compared across jurisdictions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/01/2017
Date of last participant enrolment
Anticipated
Actual
9/01/2017
Date of last data collection
Anticipated
Actual
9/01/2017
Sample size
Target
3000000
Accrual to date
Final
3000000
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment outside Australia
Country [1] 23036 0
New Zealand
State/province [1] 23036 0
Country [2] 23037 0
United Kingdom
State/province [2] 23037 0
England
Country [3] 23038 0
Canada
State/province [3] 23038 0
Ontario

Funding & Sponsors
Funding source category [1] 306811 0
Government body
Name [1] 306811 0
National Health and Medical Research Council of Australia
Country [1] 306811 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 307363 0
None
Name [1] 307363 0
Address [1] 307363 0
Country [1] 307363 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306967 0
NSW Population &Health Services Research Ethics Committee
Ethics committee address [1] 306967 0
Level 4, 1 Reserve Road
St Leonards NSW 2065
Ethics committee country [1] 306967 0
Australia
Date submitted for ethics approval [1] 306967 0
01/08/2016
Approval date [1] 306967 0
30/09/2016
Ethics approval number [1] 306967 0
2016/09/654

Summary
Brief summary
Cardiovascular disease (CVD) is a leading cause of morbidity and mortality in developed countries. Although CVD mortality rates have declined markedly over the past 3 decades, the burden remains high in many countries, and the rising prevalence of obesity and diabetes may impact on these trends. Some conditions such as coronary heart disease and stroke are significant contributors to the burden of CVD mortality. Previous international studies such as the WHO-led MONICA study investigated the contribution of changes in case fatality and event rates to trends in myocardial infarction related mortality. No recent studies have provided international comparisons across these important measures. The results of this study will show how effective changes in treatment and prevention for CVD are at a whole-population level, and the ability to compare these data across countries enhances interpretation of the relative contributions of each.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105618 0
Prof Philip Clarke
Address 105618 0
Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, UK
Country 105618 0
United Kingdom
Phone 105618 0
+44 1865 289272
Fax 105618 0
Email 105618 0
[email protected]
Contact person for public queries
Name 105619 0
Prof Philip Clarke
Address 105619 0
Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, UK
Country 105619 0
United Kingdom
Phone 105619 0
+44 1865 289272
Fax 105619 0
Email 105619 0
[email protected]
Contact person for scientific queries
Name 105620 0
Dr Lee Nedkoff
Address 105620 0
The University of Western Australia
M431, 35 Stirling Hwy, Crawley, WA 6009
Country 105620 0
Australia
Phone 105620 0
+61 8 6488 8761
Fax 105620 0
Email 105620 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
The data used for this study are de-identified population level data from each country/jurisdiction (England, New South Wales, Ontario, New Zealand), provided by the relevant Departments of Health in each country. The data are provided to researchers under agreements and ethics approvals meaning that individual level data cannot be shared outside each research institution.


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
No additional documents have been identified.