Clinical trial NCT04156061: Effect of the SCOT-HEART 2 Trial on Lifestyle.
Official title: Effect of the SCOT-HEART 2 Trial on Lifestyle and Risk Factor Modification.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Primary Prevention
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: NHS Lothian
First posted: 2019-11-07
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* MUST BE ENROLLED IN SCOTHEART 2 TRIAL

Exclusion Criteria:

* MUST BE ENROLLED IN SCOTHEART 2 TRIAL

Primary outcomes:
measure: Proportion of patients who meet National Institute for Heath and Care Excellence (NICE) recommendations on risk factor modifications
timeFrame: 6 months
Secondary outcomes:
measure: Smoking cessation
timeFrame: 6 months
measure: Weight loss
timeFrame: 6 months
measure: Blood pressure control
timeFrame: 6 months
measure: Lipid levels
timeFrame: 6 months
measure: Diabetic control
timeFrame: 6 months
measure: Adherence to medications
timeFrame: 6 months
measure: Exercise
timeFrame: 6 months
measure: Quality of life/Anxiety and Depression
timeFrame: 6 months
measure: ASSIGN score
timeFrame: 6 months
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
state: Midlothian
Study officials:
References: