Cardiovascular DiseasesSCOT-HEART 2NCT03920176
Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
A study testing Computed tomography coronary angiography and ASSIGN Score in people with Cardiovascular Diseases, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
It is hypothesised that, in individuals being considered for cardiovascular preventative therapy, computed tomography coronary angiography guided management will reduce the future risk of coronary heart disease death or non-fatal myocardial infarction compared to management guided by the current standard of care, a… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Computed tomography coronary angiography and ASSIGN Score
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,139 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jan 2020to 31 Dec 2028
- 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
- ≥40 and ≤70 years of age
- Resident in Scotland and have a Community Health Index (CHI) number
- One or more of the following risk factors:
- >60 years of age
- Current or recent (within 12 months) smoker
- Clinical diagnosis of hypertension
Show all 12Show fewer
- Known hypercholesterolaemia or total cholesterol >6.0 mmol/L or receiving statin therapy
- Diabetes mellitus
- Rheumatoid arthritis
- Systemic lupus erythematosus (SLE)
- Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease below 60 years)
- Chronic kidney disease stage 3 (estimate glomerular filtration rate 30-59 mL/min/1.73 m2).
Who cannot join
- Inability to undergo CTCA
- Known coronary heart disease or other major atherosclerotic cardiovascular disease
- Prior invasive or non-invasive coronary angiography within the last 5 years
- Chronic kidney disease stage ≥4 (estimate glomerular filtration rate <30 mL/min/1.73 m2)
- Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy
- Intolerance of all statins
- Statin therapy for >2 years.
- Previous coronary artery imaging completed specifically for cardiovascular risk assessment with a result of >10 AU.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Western General Hospital
Edinburgh, City Of Edinburgh, EH4 2XU
About this study
It is hypothesised that, in individuals being considered for cardiovascular preventative therapy, computed tomography coronary angiography guided management will reduce the future risk of coronary heart disease death or non-fatal myocardial infarction compared to management guided by the current standard of care, a cardiovascular risk score.
Read the detailed description
Prevention of cardiovascular disease is currently guided by probabilistic risk scores that both over and under treat individuals, commit most middle-aged people to pharmacotherapy, and have little evidence base. It has been demonstrated that use of computed tomography coronary angiography (CTCA) is associated with changes in the diagnosis and treatment of patients presenting with stable chest pain, and that this leads to a marked reduction in the future risk of myocardial infarction. Importantly, the proportionate reduction in coronary events was most marked in those with non-anginal chest pain irrespective of their cardiovascular risk score which again demonstrated poor discrimination. The research team propose a randomised controlled trial of at least 6,000 middle-aged individuals at risk of cardiovascular disease that will compare these two strategies of targeting preventative therapies: a probabilistic cardiovascular risk score, and screening with CTCA. This trial will determine if CTCA guided management will be associated with better targeted intervention, prevent over medicating the general population, and result in fewer future coronary heart disease events than the current standard of care using a cardiovascular risk score.
- Conditions
- Cardiovascular Diseases
- Being tested
- Computed tomography coronary angiography, ASSIGN Score
- Keywords
- Cardiology, Computed tomography coronary angiography
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography coronary angiographyDiagnostic test
CTCA >64 detector row scanner
ASSIGN ScoreOther
ASSIGN Cardiovascular Risk Score
| Study group | Role | What they receive |
|---|---|---|
| Computed tomography coronary angiography | Active comparator | Not described Receives: Diagnostic Test: Computed tomography coronary angiography |
| Assign Score only | Sham comparator | Not described Receives: Other: ASSIGN Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary heart disease death or non-fatal myocardial infarction
The primary research objective of the trial is to determine whether, in individuals with risk for cardiovascular disease, coronary heart disease screening with CTCA is associated with a reduction in the rate of coronary heart disease death or non-fatal myocardial infarction when compared to a probabilistic cardiovascular risk score approach.
Measured: 5 years
Secondary outcomes (10)
Death
Number of all-cause, cardiovascular, coronary heart disease and non-cardiovascular deaths
Measured: 5 Years
Cardiovascular Events
Number of participants who have fatal and non-fatal myocardial infarction or stroke
Measured: 5 Years
Cardiovascular Procedures
Number of Invasive coronary angiography and coronary revascularisation procedures
Measured: 5 Years
Quality of Life (EQ-5D-5L)
Quality of life measured using EQ-5D-5L instrument
Measured: 2 Years
Prescription
Rates of prescription of preventative therapies (anti-platelet, statin and angiotensin-converting enzyme inhibitor therapies)
Measured: 5 Years
Lifestyle Modification
Uptake of lifestyle modifications (smoking, exercise and diet) measured using self-reported questionnaire
Measured: 2 Years
Health Economics
Health economic assessment of cost-effectiveness
Measured: 2 Years
Cholesterol
Serum cholesterol concentration
Measured: 5 Years
Disadvantages of CTCA- Radiation
Radiation dose (mGy-cm)
Measured: 5 Years
Disadvantages of CTCA- incidental findings
Number of participants with incidental findings from CTCA
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start13 Jan 2020
- Primary completion19 Dec 2025
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,139 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
- Investigators
- David E Newby, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920176
- Sponsor's protocol ID
- IRAS ID: 261185
- Acronym
- SCOT-HEART 2
- Status last verified
- Jan 2026
- First submitted
- 16 Apr 2019
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The intention is to share anonymised data with external collaborators and scientists. The data will be available one year after the primary paper has been published (anticipated to be in 2027) .
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
- ClinicalTrials.gov ID
- NCT03920176
- Acronym / sponsor ID
- SCOT-HEART 2 / IRAS ID: 261185
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiology, Computed tomography coronary angiography
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,139 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- British Heart Foundation, NHS Lothian
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Apr 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.
It is hypothesised that, in individuals being considered for cardiovascular preventative therapy, computed tomography coronary angiography guided management will reduce the future risk of coronary heart disease death or non-fatal myocardial infarction compared to management guided by the current standard of care, a cardiovascular risk score.
Detailed description
Prevention of cardiovascular disease is currently guided by probabilistic risk scores that both over and under treat individuals, commit most middle-aged people to pharmacotherapy, and have little evidence base. It has been demonstrated that use of computed tomography coronary angiography (CTCA) is associated with changes in the diagnosis and treatment of patients presenting with stable chest pain, and that this leads to a marked reduction in the future risk of myocardial infarction. Importantly, the proportionate reduction in coronary events was most marked in those with non-anginal chest pain irrespective of their cardiovascular risk score which again demonstrated poor discrimination. The research team propose a randomised controlled trial of at least 6,000 middle-aged individuals at risk of cardiovascular disease that will compare these two strategies of targeting preventative therapies: a probabilistic cardiovascular risk score, and screening with CTCA. This trial will determine if CTCA guided management will be associated with better targeted intervention, prevent over medicating the general population, and result in fewer future coronary heart disease events than the current standard of care using a cardiovascular risk score.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computed tomography coronary angiography | Active comparator | Diagnostic Test: Computed tomography coronary angiography |
| Assign Score only | Sham comparator | Other: ASSIGN Score |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥40 and ≤70 years of age
- Resident in Scotland and have a Community Health Index (CHI) number
- One or more of the following risk factors:
Key exclusion criteria (8 listed)
- Inability to undergo CTCA
- Known coronary heart disease or other major atherosclerotic cardiovascular disease
- Prior invasive or non-invasive coronary angiography within the last 5 years
- Chronic kidney disease stage ≥4 (estimate glomerular filtration rate <30 mL/min/1.73 m2)
- Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy
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 |
|---|---|---|
| Computed tomography coronary angiographyCTCA >64 detector row scanner | Diagnostic test | Computed tomography coronary angiography |
| ASSIGN ScoreASSIGN Cardiovascular Risk Score | Other | Assign Score only |
Primary outcome
Coronary heart disease death or non-fatal myocardial infarction
Time frame: 5 years
The primary research objective of the trial is to determine whether, in individuals with risk for cardiovascular disease, coronary heart disease screening with CTCA is associated with a reduction in the rate of coronary heart disease death or non-fatal myocardial infarction when compared to a probabilistic cardiovascular risk score approach.
10 secondary outcomes
Death
Time frame: 5 Years
Cardiovascular Events
Time frame: 5 Years
Cardiovascular Procedures
Time frame: 5 Years
Quality of Life (EQ-5D-5L)
Time frame: 2 Years
Prescription
Time frame: 5 Years
Lifestyle Modification
Time frame: 2 Years
Health Economics
Time frame: 2 Years
Cholesterol
Time frame: 5 Years
Disadvantages of CTCA- Radiation
Time frame: 5 Years
Disadvantages of CTCA- incidental findings
Time frame: 5 Years
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 15 Jan 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The intention is to share anonymised data with external collaborators and scientists. The data will be available one year after the primary paper has been published (anticipated to be in 2027) .
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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.
David E Newby principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed tomography coronary angiography and ASSIGN Score in people with Cardiovascular Diseases, 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 12 inclusion and 8 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 15 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
Coronary heart disease death or non-fatal myocardial infarction (time frame: 5 years). 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 15 Jan 2026.