Effect of the SCOT-HEART 2 Trial on Lifestyle.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Primary Prevention
• Intervention / Treatment: Other: Delivery of CT scan results

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammed N Meah, MB ChB; Phone Number: 07921238123; Email: m.meah@ed.ac.uk

Study Locations

• United Kingdom
  • Midlothian
    • Edinburgh, Midlothian, United Kingdom, EH16 4SB
      • Recruiting
      • University of Edinburgh
      • Contact: Mohammed N Meah, MBChB, MRCP; Phone Number: 07921238123; Email: m.meah@ed.ac.uk
      • Contact: David E Newby, BA BSc(Hons) PhD BM DM; Phone Number: 01312426515; Email: d.e.newby@ed.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• MUST BE ENROLLED IN SCOTHEART 2 TRIAL

Exclusion Criteria:

• MUST BE ENROLLED IN SCOTHEART 2 TRIAL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: 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.
ACTIVE_COMPARATOR: 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.	Other: Delivery of CT scan results; Method of results delivery - verbal or visual.
ACTIVE_COMPARATOR: 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.	Other: Delivery of CT scan results; Method of results delivery - verbal or visual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation	Proportion of patients who changed smoking habits (%)	6 months
Weight loss	Measure change in weight via body mass index and waist circumference (%)	6 months
Blood pressure control	Change in blood pressure control through lifestyle/compliance with medications (%)	6 months
Lipid levels	Change in serum lipid levels through lifestyle/compliace with medications (%)	6 months
Diabetic control	Change in glycosylated haemoglobin (HbA1c) (%)	6 months
Adherence to medications	Change in compliance with medications tracked through questionnaire	6 months
Exercise	Change in activity levels measured through activity monitoring (step count over 2 weeks) and international physical activity questionnaire	6 months
Quality of life/Anxiety and Depression	Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)	6 months
ASSIGN score	Change in ASSIGN score as a result of lifestyle / risk factor modification (%)	6 months

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian; British Heart Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2020
• Primary Completion (ANTICIPATED): April 30, 2023
• Study Completion (ANTICIPATED): August 30, 2023

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (ACTUAL): November 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: AC19113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised participant data will be made available to other researchers
• IPD Sharing Time Frame: To be determined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No