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Trial registered on ANZCTR


Registration number
ACTRN12612000937819
Ethics application status
Approved
Date submitted
31/08/2012
Date registered
4/09/2012
Date last updated
4/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of Co-ordinated Lifestyle Advice in Patients Admitted with an Acute Coronary Syndrome
Scientific title
A randomised controlled trial to evaluate the effect of co-ordinated lifestyle advice on the proportion of patients achieving clinical targets for modifiable cardiovascular risk factors at nine months in patients admitted with an acute coronary syndrome
Secondary ID [1] 281127 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 287297 0
Cardiovascular disease 287298 0
Condition category
Condition code
Cardiovascular 287627 287627 0 0
Coronary heart disease
Metabolic and Endocrine 287635 287635 0 0
Diabetes
Public Health 287636 287636 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After randomisation to the intervention group participants will be contacted by telephone by the research nurse to discuss contents of a composite package of information regarding options for physical activity (green prescription), smoking cessation, diet and exercise. This information will then be posted to the patient and their GP. Participants will also be invited to attend the 12-week Cardiac Exercise Rehabilitation Programme, (run at Massey University) within the 9 months of the study. The research nurse will also contact the patients GP or practice nurse to inform them of the patients participation, the content of the information package and to encourage the practice to actively engage the patient. The focus will be to optimise patient utilisation of existing healthcare resources/services available in the primary health sector. Participants will be asked to attend their GP for an initial consultation shortly after discharge from hospital and then for regular check-ups at three, six and nine months with a view to optimising risk factor management. Patients and their GP will be contacted by the research nurse at 3, 6 and 9 months to remind them of the importance of this consultation. No further direct contact or intervention will be undertaken by the research team.
Intervention code [1] 285585 0
Lifestyle
Intervention code [2] 285591 0
Prevention
Comparator / control treatment
In the Usual Care (control) group the participant’s General Practitioner (GP) will be notified of their inclusion in the study, but no other communication or intervention will be delivered. Following discharge the usual care group will be asked to contact their GP for follow up of their acute coronary syndrome and elevated glucose during the hospital admission. The participant and GP will also be asked to conduct a review at nine months that includes clinical measurements and blood tests.
Control group
Active

Outcomes
Primary outcome [1] 287878 0
The primary outcome measure is the proportion of patients achieving clinical targets for modifiable cardiovascular risk factors at nine months. These included not smoking, systolic blood pressure <130 mmHg, total cholesterol (TC) < 4.0 mmol/l, LDL cholesterol (LDL-C) < 2 mmol/L, HDL cholesterol (HDL-C) greater than or equal to 1.0 mmol/L, fasting triglycerides (FTG) <1.7 mmol/L, total:HDL cholesterol ratio < 4.0 and BMI < 25 kg/m2.
Timepoint [1] 287878 0
Baseline and 9 Months
Secondary outcome [1] 298975 0
Weight (kg)
Timepoint [1] 298975 0
Baseline and 9 months
Secondary outcome [2] 298985 0
waist circumference (cm)
Timepoint [2] 298985 0
Baseline and 9 months
Secondary outcome [3] 298986 0
Fasting glucose (mmol/l)
Timepoint [3] 298986 0
Baseline and 9 months
Secondary outcome [4] 298987 0
Glycated haemoglobin (HbA1c)
Timepoint [4] 298987 0
Baseline and 9 months

Eligibility
Key inclusion criteria
People admitted to the Wellington Regional Heart and Lung Unit (WRHLU) with acute coronary syndromes and either a fasting plasma glucose greater than or equal to 6.1 mmol/L, and/or a HbA1c > 6 % (42 mmol/mol).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded if they live outside of the Wellington region, have known type 1 or type 2 diabetes mellitus or have a known malignancy.

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)
Study participants will be randomised on a 1:1 ratio to either a Usual Care (control) or to an Intervention group. Allocation to group will be concealed by using an offsite holder of teh allocation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will a computer-generated random allocation sequence constructed and performed by an independent statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4518 0
New Zealand
State/province [1] 4518 0
Wellington

Funding & Sponsors
Funding source category [1] 285910 0
Government body
Name [1] 285910 0
Health REsearch Council of New Zealand
Address [1] 285910 0
P.O. Box 5541
Wellesley Street
Auckland 1141
Country [1] 285910 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jeremy Krebs
Address
Endocrine Diabetes and Research Centre
Capital and Coast Health
Private Bag 7902
Wellington
Country
New Zealand
Secondary sponsor category [1] 284730 0
Individual
Name [1] 284730 0
Dr Rachel Page
Address [1] 284730 0
School of Health and Social Services
Massey University
Private Bag 756
Wellington 6140
Country [1] 284730 0
New Zealand
Secondary sponsor category [2] 284731 0
Other
Name [2] 284731 0
Compass Health Primary Care Network
Address [2] 284731 0
PO Box 27 380
Marion Square
Wellington 6141
Country [2] 284731 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287938 0
Ministry of Health Central Regional Ethics Committee
Ethics committee address [1] 287938 0
Ministry of Health
P.O. Box 5013
Wellington 6011
Ethics committee country [1] 287938 0
New Zealand
Date submitted for ethics approval [1] 287938 0
Approval date [1] 287938 0
30/04/2009
Ethics approval number [1] 287938 0
CEN 09/04/019

Summary
Brief summary
Abnormal glucose tolerance is a strong predictor of future cardiovascular events as well as development of type 2 diabetes mellitus. Multiple studies have previously demonstrated that patients admitted with acute coronary syndromes who have no pre-existing diagnosis of diabetes commonly have abnormal glucose tolerance or diabetes.

Evidence already exists that intervention in individuals with impaired glucose tolerance prevents the evolution to T2DM. Many resources to help these at-risk individuals are already present in the primary health care sector, but these are often not engaged once a person is discharged from hospital.

We hypothesise that directed support and guidance in the primary healthcare setting in the first year of discharge from hospital, will provide the at-risk individuals with the tools to take charge of their life and ultimately reduce the risk of them having further cardiac events or developing T2DM.

The aim of this study is to determine whether coordinated diet and lifestyle modification can improve the metabolic and cardiovascular risk profile of patients presenting with ACS found to have impaired glucose metabolism when compared to usual care.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34643 0
Address 34643 0
Country 34643 0
Phone 34643 0
Fax 34643 0
Email 34643 0
Contact person for public queries
Name 17890 0
Dr Jeremy Krebs
Address 17890 0
Endocrine, Diabetes and REsearch Centre
Capital and Coast Health
Private Bag 7902
Wellington
Country 17890 0
New Zealand
Phone 17890 0
+64 4 3855 999
Fax 17890 0
+64 4 3855819
Email 17890 0
jeremy.krebs@ccdhb.org.nz
Contact person for scientific queries
Name 8818 0
Dr Jeremy Krebs
Address 8818 0
Endocrine, Diabetes and REsearch Centre
Capital and Coast Health
Private Bag 7902
Wellington
Country 8818 0
New Zealand
Phone 8818 0
+64 4 3855 999
Fax 8818 0
+64 4 3855819
Email 8818 0
jeremy.krebs@ccdhb.org.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary