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NCT Number: NCT04156061

Effect of the SCOT-HEART 2 Trial on Lifestyle.

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Primary Prevention Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Edinburgh

Edinburgh, Midlothian, EH16 4SB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • MUST BE ENROLLED IN SCOTHEART 2 TRIAL

Exclusion criteria

  • MUST BE ENROLLED IN SCOTHEART 2 TRIAL

Treatment and study plan

Delivery of CT scan results

Other

Method of results delivery - verbal or visual.

Primary outcomes

  1. Proportion of patients who meet National Institute for Heath and Care Excellence (NICE) recommendations on risk factor modifications

    Time frame: 6 months

    The primary endpoint will be the proportion of patients who meet NICE recommendations on diet, smoking, weight and activity levels (%)

Secondary outcomes

  1. Smoking cessation

    Time frame: 6 months

    Proportion of patients who changed smoking habits (%)

  2. Weight loss

    Time frame: 6 months

    Measure change in weight via body mass index and waist circumference (%)

  3. Blood pressure control

    Time frame: 6 months

    Change in blood pressure control through lifestyle/compliance with medications (%)

  4. Lipid levels

    Time frame: 6 months

    Change in serum lipid levels through lifestyle/compliace with medications (%)

  5. Diabetic control

    Time frame: 6 months

    Change in glycosylated haemoglobin (HbA1c) (%)

  6. Adherence to medications

    Time frame: 6 months

    Change in compliance with medications tracked through questionnaire

  7. Exercise

    Time frame: 6 months

    Change in activity levels measured through activity monitoring (step count over 2 weeks) and international physical activity questionnaire

  8. Quality of life/Anxiety and Depression

    Time frame: 6 months

    Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)

  9. ASSIGN score

    Time frame: 6 months

    Change in ASSIGN score as a result of lifestyle / risk factor modification (%)

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • British Heart Foundation
  • NHS Lothian

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2027
First posted
Nov 7, 2019
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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