This study will recruit 400 participants who are taking part in the Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (SCOT-HEART 2) trial. The investigator will assess diet, activity and habits at the start of the study and 6 months later. This will help us understand the effects taking part in the study may have on lifestyle. In addition, for participants who have CT scans, the investigator will present the results of the heart from the CT scan. This will help us understand how best to explain the results of the CT scan to patients.
This is a sub-study of the SCOT-HEART 2 trial (which aims to determine the best way to prevent heart attacks). The purpose of this sub-study is to determine the effect of getting information on heart disease risk on lifestyle. At present doctors usually use a "risk score" to identify people at risk of heart disease who may benefit from medical treatment. In the SCOT-HEART 2 study the investigator will compare this "risk score" to a specialised heart scan (a computed tomography coronary angiogram or CTCA scan). In this study the investigator would like to understand more about the effects of receiving this information about the heart on lifestyle, including effects on smoking, diet and activity. This study will recruit 400 participants who are taking part in the SCOT-HEART 2 trial. The investigator will assess lifestyle by using a detailed questionnaire which will be done at the start of the study and 6 months later. The investigator will also perform some simple investigations including a carbon monoxide breath test, blood pressure tests and measurements of activity such as step counts. This will help us understand the effects on lifestyle of getting information about a "risk score" or having a CT scan. In addition, for people who have CT scans the investigator will either provide a verbal explanation of the results, as is usual, or show pictures of the heart from the CT scan. This will help us understand how best to explain the results of the CT scan to partipants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
Method of results delivery - verbal or visual.
University of Edinburgh
Edinburgh, Midlothian, United Kingdom
Proportion of patients who meet National Institute for Heath and Care Excellence (NICE) recommendations on risk factor modifications
The primary endpoint will be the proportion of patients who meet NICE recommendations on diet, smoking, weight and activity levels (%)
Time frame: 6 months
Smoking cessation
Proportion of patients who changed smoking habits (%)
Time frame: 6 months
Weight loss
Measure change in weight via body mass index and waist circumference (%)
Time frame: 6 months
Blood pressure control
Change in blood pressure control through lifestyle/compliance with medications (%)
Time frame: 6 months
Lipid levels
Change in serum lipid levels through lifestyle/compliace with medications (%)
Time frame: 6 months
Diabetic control
Change in glycosylated haemoglobin (HbA1c) (%)
Time frame: 6 months
Adherence to medications
Change in compliance with medications tracked through questionnaire
Time frame: 6 months
Exercise
Change in activity levels measured through activity monitoring (step count over 2 weeks) and international physical activity questionnaire
Time frame: 6 months
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NONE
Enrollment
400
Quality of life/Anxiety and Depression
Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)
Time frame: 6 months
ASSIGN score
Change in ASSIGN score as a result of lifestyle / risk factor modification (%)
Time frame: 6 months