Effect of the SCOT-HEART 2 Trial on Lifestyle.

NCT ID: NCT04156061

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2027-07-07

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.

Conditions

Coronary Artery Disease; Primary Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ASSIGN score

The baseline assessment will be completed on the same day as consent is gained. Every patients will complete a comprehensive assessment including questionnaires and objective assessments.

Patients randomised to standard care with ASSIGN score alone (n=200) will be invited back approximately 6 months after baseline assessment. The detailed questionnaire, breath test, blood pressure monitoring, and 2-week activity monitor will be repeated. Bloods will be retaken to look at change in lipid levels and HbA1c where appropriate - no more than 30mls will be required.

Group Type: NO_INTERVENTION

No interventions assigned to this group

CTCA - visual report

Those in the CTCA group will be further randomised into review with or without CT images.

The review WITH images (VISUAL REPORT N=100) group will have results delivered by the principal investigator (a trained Cardiology Registrar) to ensure a standardised approach to relaying information. These results will be preliminary and focused only on whether the patient has evidence of coronary disease or not. A full report describing the extent of coronary disease, other cardiac problems and incidental findings will follow as per the SCOT-HEART-2 protocol. Patients will be made aware that the presented findings are a focused preliminary report and that a more detailed formal report will follow.

Group Type: ACTIVE_COMPARATOR

Delivery of CT scan results

Intervention Type: OTHER

Method of results delivery - verbal or visual.

CTCA - verbal report

The baseline assessment will be completed on the same day as consent is gained. Every patients will complete a comprehensive assessment including questionnaires and objective assessments.

Those in the CTCA group will be further randomised into review with or without CT images.

The review WITHOUT images (VERBAL REPORT N=100) group will have results delivered by the principal investigator (a trained Cardiology Registrar) to ensure a standardised approach to relaying information. These results will be preliminary and focused only on whether the patient has evidence of coronary disease or not. A full report describing the extent of coronary disease, other cardiac problems and incidental findings will follow as per the SCOT-HEART-2 protocol. Patients will be made aware that the presented findings are a focused preliminary report and that a more detailed formal report will follow.

Group Type: ACTIVE_COMPARATOR

Delivery of CT scan results

Intervention Type: OTHER

Method of results delivery - verbal or visual.

Interventions

Delivery of CT scan results

Method of results delivery - verbal or visual.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• MUST BE ENROLLED IN SCOTHEART 2 TRIAL

Exclusion Criteria

• MUST BE ENROLLED IN SCOTHEART 2 TRIAL

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British Heart Foundation

OTHER

Sponsor Role: collaborator

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Edinburgh

Edinburgh, Midlothian, United Kingdom

Countries

United Kingdom

Other Identifiers

AC19113

Identifier Type: -

Identifier Source: org_study_id