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A Randomised Controlled Trial of Co-ordinated Lifestyle Advice in Patients Admitted with an Acute Coronary Syndrome

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000937819
Enrollment
50
Registered
2012-09-04
Start date
2009-09-25
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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. Th

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.

Sponsors

Dr Jeremy Krebs
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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).

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026