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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Diagnostic Test: Computed tomography coronary angiography
* Other: ASSIGN Score


Participation Criteria
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Eligibility Criteria
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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 (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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Computed tomography coronary angiography<br> | Diagnostic Test: Computed tomography coronary angiography<br>* CTCA >64 detector row scanner<br>Other: ASSIGN Score<br>* ASSIGN Cardiovascular Risk Score<br>|
| Sham Comparator: Assign Score only<br> | Other: ASSIGN Score<br>* ASSIGN Cardiovascular Risk Score<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiology, Computed tomography coronary angiography