Coronary Artery DiseaseNCT04156061
Effect of the SCOT-HEART 2 Trial on Lifestyle.
A study testing Delivery of CT scan results in people with Coronary Artery Disease and Primary Prevention, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Primary Prevention
- What is being tested?
- Delivery of CT scan results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Sep 2020to 7 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MUST BE ENROLLED IN SCOTHEART 2 TRIAL
Who cannot join
- MUST BE ENROLLED IN SCOTHEART 2 TRIAL
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh
Edinburgh, Midlothian, EH16 4SB
About this study
Official title: 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.
Read the 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
- Being tested
- Delivery of CT scan results
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivery of CT scan resultsOther
Method of results delivery - verbal or visual.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Delivery of CT scan results |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 6 months
Secondary outcomes (9)
Smoking cessation
Proportion of patients who changed smoking habits (%)
Measured: 6 months
Weight loss
Measure change in weight via body mass index and waist circumference (%)
Measured: 6 months
Blood pressure control
Change in blood pressure control through lifestyle/compliance with medications (%)
Measured: 6 months
Lipid levels
Change in serum lipid levels through lifestyle/compliace with medications (%)
Measured: 6 months
Diabetic control
Change in glycosylated haemoglobin (HbA1c) (%)
Measured: 6 months
Adherence to medications
Change in compliance with medications tracked through questionnaire
Measured: 6 months
Exercise
Change in activity levels measured through activity monitoring (step count over 2 weeks) and international physical activity questionnaire
Measured: 6 months
Quality of life/Anxiety and Depression
Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)
Measured: 6 months
ASSIGN score
Change in ASSIGN score as a result of lifestyle / risk factor modification (%)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start28 Sep 2020
- Primary completion12 Jan 2024
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156061
- Sponsor's protocol ID
- AC19113
- Status last verified
- Sep 2025
- First submitted
- 1 Nov 2019
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised participant data will be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the SCOT-HEART 2 Trial on Lifestyle and Risk Factor Modification.
- ClinicalTrials.gov ID
- NCT04156061
- Acronym / sponsor ID
- AC19113
- Conditions
- Coronary Artery Disease, Primary Prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- British Heart Foundation, NHS Lothian
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Delivery of CT scan resultsThose 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. |
| CTCA - verbal report | Active comparator | Other: Delivery of CT scan resultsThe 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- MUST BE ENROLLED IN SCOTHEART 2 TRIAL
Key exclusion criteria (1 listed)
- MUST BE ENROLLED IN SCOTHEART 2 TRIAL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delivery of CT scan resultsMethod of results delivery - verbal or visual. | Other | CTCA - verbal report, CTCA - visual report |
Primary outcome
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 (%)
9 secondary outcomes
Smoking cessation
Time frame: 6 months
Weight loss
Time frame: 6 months
Blood pressure control
Time frame: 6 months
Lipid levels
Time frame: 6 months
Diabetic control
Time frame: 6 months
Adherence to medications
Time frame: 6 months
Exercise
Time frame: 6 months
Quality of life/Anxiety and Depression
Time frame: 6 months
ASSIGN score
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Yes. Anonymised participant data will be made available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery of CT scan results in people with Coronary Artery Disease and Primary Prevention, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who meet National Institute for Heath and Care Excellence (NICE) recommendations on risk factor modifications (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.