NCT04156061

Effect of the SCOT-HEART 2 Trial on Lifestyle.

Effect of the SCOT-HEART 2 Trial on Lifestyle and Risk Factor Modification.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Primary Prevention

Interventions

Type	Name	Description
OTHER	Delivery of CT scan results	Method of results delivery - verbal or visual.

Timeline

• Start date: 2020-09-28
• Primary completion: 2024-01-12
• Completion: 2027-07-07
• First posted: 2019-11-07
• Last updated: 2025-11-18

Locations

1 site across 1 country: United Kingdom