Coronary Artery Disease, Primary Prevention
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERDelivery of CT scan results
Method of results delivery - verbal or visual.
Sponsors
British Heart Foundation
NHS Lothian
University of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* MUST BE ENROLLED IN SCOTHEART 2 TRIAL
Exclusion criteria
* MUST BE ENROLLED IN SCOTHEART 2 TRIAL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who meet National Institute for Heath and Care Excellence (NICE) recommendations on risk factor modifications | 6 months | The primary endpoint will be the proportion of patients who meet NICE recommendations on diet, smoking, weight and activity levels (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | 6 months | Measure change in weight via body mass index and waist circumference (%) |
| Blood pressure control | 6 months | Change in blood pressure control through lifestyle/compliance with medications (%) |
| Lipid levels | 6 months | Change in serum lipid levels through lifestyle/compliace with medications (%) |
| Diabetic control | 6 months | Change in glycosylated haemoglobin (HbA1c) (%) |
| Smoking cessation | 6 months | Proportion of patients who changed smoking habits (%) |
| Exercise | 6 months | Change in activity levels measured through activity monitoring (step count over 2 weeks) and international physical activity questionnaire |
| Quality of life/Anxiety and Depression | 6 months | Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%) |
| ASSIGN score | 6 months | Change in ASSIGN score as a result of lifestyle / risk factor modification (%) |
| Adherence to medications | 6 months | Change in compliance with medications tracked through questionnaire |
Countries
United Kingdom
Outcome results
None listed