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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Diagnostic test: Computed tomography coronary angiography; Other: ASSIGN 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 Type: Interventional
• Enrollment (Actual): 6139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • City Of Edinburgh
    • Edinburgh, City Of Edinburgh, United Kingdom, EH4 2XU
      • Western General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Computed tomography coronary angiography	Diagnostic test: Computed tomography coronary angiography; CTCA >64 detector row scanner
Sham Comparator: Assign Score only	Other: ASSIGN Score; ASSIGN Cardiovascular Risk Score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Number of all-cause, cardiovascular, coronary heart disease and non-cardiovascular deaths	5 Years
Cardiovascular Events	Number of participants who have fatal and non-fatal myocardial infarction or stroke	5 Years
Cardiovascular Procedures	Number of Invasive coronary angiography and coronary revascularisation procedures	5 Years
Quality of Life (EQ-5D-5L)	Quality of life measured using EQ-5D-5L instrument	2 Years
Prescription	Rates of prescription of preventative therapies (anti-platelet, statin and angiotensin-converting enzyme inhibitor therapies)	5 Years
Lifestyle Modification	Uptake of lifestyle modifications (smoking, exercise and diet) measured using self-reported questionnaire	2 Years
Health Economics	Health economic assessment of cost-effectiveness	2 Years
Cholesterol	Serum cholesterol concentration	5 Years
Disadvantages of CTCA- Radiation	Radiation dose (mGy-cm)	5 Years
Disadvantages of CTCA- incidental findings	Number of participants with incidental findings from CTCA	5 Years

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian; British Heart Foundation
• Investigators: Principal Investigator: David E Newby, University of Edinburgh

Publications and helpful links

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): December 19, 2025
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cardiology; Computed tomography coronary angiography
• Additional Relevant MeSH Terms: Vascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Cardiovascular Diseases
• Other Study ID Numbers: IRAS ID: 261185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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) .
• IPD Sharing Time Frame: After 2027.
• IPD Sharing Access Criteria: Requests can be made by email from 2027.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; 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