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NCT Number: NCT03920176

Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western General Hospital

Edinburgh, City Of Edinburgh, EH4 2XU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥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
  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Computed Tomography Coronary Angiography

Diagnostic Test

CTCA >64 detector row scanner

ASSIGN Score

Other

ASSIGN Cardiovascular Risk Score

Primary outcomes

  1. 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.

Secondary outcomes

  1. Death

    Time frame: 5 Years

    Number of all-cause, cardiovascular, coronary heart disease and non-cardiovascular deaths

  2. Cardiovascular Events

    Time frame: 5 Years

    Number of participants who have fatal and non-fatal myocardial infarction or stroke

  3. Cardiovascular Procedures

    Time frame: 5 Years

    Number of Invasive coronary angiography and coronary revascularisation procedures

  4. Quality of Life (EQ-5D-5L)

    Time frame: 2 Years

    Quality of life measured using EQ-5D-5L instrument

  5. Prescription

    Time frame: 5 Years

    Rates of prescription of preventative therapies (anti-platelet, statin and angiotensin-converting enzyme inhibitor therapies)

  6. Lifestyle Modification

    Time frame: 2 Years

    Uptake of lifestyle modifications (smoking, exercise and diet) measured using self-reported questionnaire

  7. Health Economics

    Time frame: 2 Years

    Health economic assessment of cost-effectiveness

  8. Cholesterol

    Time frame: 5 Years

    Serum cholesterol concentration

  9. Disadvantages of CTCA- Radiation

    Time frame: 5 Years

    Radiation dose (mGy-cm)

  10. Disadvantages of CTCA- incidental findings

    Time frame: 5 Years

    Number of participants with incidental findings from CTCA

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • British Heart Foundation
  • NHS Lothian

Registry information

Acronym: SCOT-HEART 2

Important dates

Study start
2020
Primary completion
2025
Study completion
2028
First posted
Apr 18, 2019
Registry last updated
Jan 15, 2026

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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