Effect of the SCOT-HEART 2 Trial on Lifestyle.

NCT04156061 | Active Not Recruiting

• 1 other identifier: AC19113
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Primary Prevention

Outcome Measures

Primary Outcomes (1)

• 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 (%)

  6 months

Secondary Outcomes (9)

• Smoking cessation

  6 months

• Weight loss

  6 months

• Blood pressure control

  6 months

• Lipid levels

  6 months

• Diabetic control

  6 months

Study Arms (3)

ASSIGN score

NO INTERVENTION

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.

CTCA - visual report

ACTIVE COMPARATOR

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.

Other: Delivery of CT scan results

CTCA - verbal report

ACTIVE COMPARATOR

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.

Other: Delivery of CT scan results

Interventions

Delivery of CT scan results OTHER

Method of results delivery - verbal or visual.

CTCA - verbal report; CTCA - visual report

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MUST BE ENROLLED IN SCOTHEART 2 TRIAL

You may not qualify if:

• MUST BE ENROLLED IN SCOTHEART 2 TRIAL

Sponsors & Collaborators

• University of Edinburgh: lead
• British Heart Foundation: collaborator
• NHS Lothian: collaborator

Study Sites (1)

University of Edinburgh

Edinburgh, Midlothian, EH16 4SB, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 7, 2019
• Study Start: September 28, 2020
• Primary Completion: January 12, 2024
• Study Completion (Estimated): July 7, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: To be determined

Locations

GB (1)