Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000615381
Ethics application status
Approved
Date submitted
21/04/2017
Date registered
28/04/2017
Date last updated
21/08/2020
Date data sharing statement initially provided
20/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of intensive risk factor modification in patients referred to a public clinic with chest pain.
Scientific title
In chest pain patients, does an intensive absolute cardiovascular risk guided risk factor management strategy (compared to usual care) improve subsequent cardiovascular risk
Secondary ID [1] 284867 0
Nil known
Universal Trial Number (UTN)
U1111-1158-3546
Trial acronym
ARCPAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 292269 0
Chest pain 303015 0
Condition category
Condition code
Cardiovascular 292625 292625 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomized to the intervention group will have a detailed discussion (with a cardiology nurse and treating cardiologist) regarding their cardiovascular risk, based on their 5-year risk calculation (using the Australian Absolute Risk Calculator - cvdcheck.org). This discussion will occur at the time of initial review at the Chest Pain Clinic, and is estimated to take around 40 minutes. The treating cardiologist will then develop an individualised risk management strategy in consultation with the patient, and communicated with their General Practitioner. The strategy will be based on the current recommendations of the National Heart Foundation Guidelines for management of cardiovascular risk. This may include lifestyle advice (exercise, dietary), prescription of lipid or blood pressure therapy where indicated, referral to the hospital's smoking cessation clinic +/- prescription of nicotine replacement therapy.

Patients will be followed up via telephone (by a cardiology nurse) at 3, 6 and 9 month intervals, with in-person follow up at 12 months. At 12 months and five years, participants' absolute risk profile will be reassessed. Each contact point will provide an opportunity to monitor adherence to the agreed risk management strategy.
Intervention code [1] 289673 0
Prevention
Comparator / control treatment
Usual care, meaning referral back to primary care (general practitioner) for risk factor management, with basic advice from the chest pain clinic
Control group
Active

Outcomes
Primary outcome [1] 292465 0
Individual subject's 5-year Absolute Cardiovascular Risk score (calculated using the Australian Absolute Risk Calculator - cvdcheck.org.au).
Timepoint [1] 292465 0
12 months post presentation
Secondary outcome [1] 309030 0
Lipid profile by serum assay
Timepoint [1] 309030 0
12 months and 5 years post presentation
Secondary outcome [2] 334198 0
Blood pressure by sphygmomanometry
Timepoint [2] 334198 0
12 months and 5 years post presentation
Secondary outcome [3] 334199 0
Smoking status - self reported by participant
Timepoint [3] 334199 0
12 months and 5 years post presentation
Secondary outcome [4] 334200 0
Body mass index by measurement of weight (kg) and height (cm)
Timepoint [4] 334200 0
12 months and 5 years post presentation
Secondary outcome [5] 334201 0
Quality of life score as assessed by SF-36 questionnnaire
Timepoint [5] 334201 0
12 months and 5 years post presentation
Secondary outcome [6] 334202 0
Physical activity level as assessed by IPAQ questionnaire
Timepoint [6] 334202 0
12 months and 5 years post presentation
Secondary outcome [7] 334203 0
Major Adverse Cardiovascular Events as determined by history and review of medical records
Timepoint [7] 334203 0
12 months and 5 years post presentation

Eligibility
Key inclusion criteria
New patients referred to the chest pain service with uncomplicated chest pain suspicious of cardiac aetiology with intermediate to high baseline cardiovascular risk (>8% risk over 5 years)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No prior cardiac history
Pregnancy
Subsequent primary cardiac diagnosis

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Suitable patients will be enrolled at presentation to the Chest Pain Clinic. Those with absolute cardiovascular risk >8% over 5 years will then be randomised (central, web based block randomization) to intervention or control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Web based, block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pilot study

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2014
Date of last participant enrolment
Anticipated
19/12/2017
Actual
19/12/2017
Date of last data collection
Anticipated
19/12/2022
Actual
5/02/2020
Sample size
Target
250
Accrual to date
Final
221
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 2671 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 8344 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 289483 0
Charities/Societies/Foundations
Name [1] 289483 0
Tasmanian Community Fund
Country [1] 289483 0
Australia
Primary sponsor type
Hospital
Name
Royal Hobart Hospital
Address
Liverpool St
Hobart
Tas 7000
Country
Australia
Secondary sponsor category [1] 288167 0
University
Name [1] 288167 0
University of Tasmania
Address [1] 288167 0
Medical Sciences Building
Campbell St
Hobart
Tas 7000
Country [1] 288167 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291239 0
Tasmanian Human and Medical Research Ethics Committee
Ethics committee address [1] 291239 0
Ethics committee country [1] 291239 0
Australia
Date submitted for ethics approval [1] 291239 0
Approval date [1] 291239 0
27/05/2014
Ethics approval number [1] 291239 0
H0014029

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49458 0
Dr J Andrew Black
Address 49458 0
Department of Cardiology
Royal Hobart Hospital
Liverpool St
Hobart Tas 7000
Country 49458 0
Australia
Phone 49458 0
+61362228620
Fax 49458 0
Email 49458 0
[email protected]
Contact person for public queries
Name 49459 0
J Andrew Black
Address 49459 0
Department of Cardiology
Royal Hobart Hospital
Liverpool St
Hobart Tas 7000
Country 49459 0
Australia
Phone 49459 0
+61362228620
Fax 49459 0
Email 49459 0
[email protected]
Contact person for scientific queries
Name 49460 0
J Andrew Black
Address 49460 0
Department of Cardiology
Royal Hobart Hospital
Liverpool St
Hobart Tas 7000
Country 49460 0
Australia
Phone 49460 0
+61362228620
Fax 49460 0
Email 49460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified baseline data and primary and secondary outcomes
When will data be available (start and end dates)?
From October 2020, no end date determined
Available to whom?
Case by case basis as determined by primary investigator
Available for what types of analyses?
Data release considered for any purpose
How or where can data be obtained?
By contacting the principal investigator - [email protected]


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.