Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
- Conditions
- Cardiovascular Diseases
- Interventions
- Other: ASSIGN ScoreDiagnostic Test: Computed tomography coronary angiography
- Registration Number
- NCT03920176
- Lead Sponsor
- University of Edinburgh
- Brief 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Assign Score only ASSIGN Score - Computed tomography coronary angiography Computed tomography coronary angiography -
- Primary Outcome Measures
Name Time Method Coronary heart disease death or non-fatal myocardial infarction 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 Outcome Measures
Name Time Method Prescription 5 Years Rates of prescription of preventative therapies (anti-platelet, statin and angiotensin-converting enzyme inhibitor therapies)
Lifestyle Modification 2 Years Uptake of lifestyle modifications (smoking, exercise and diet) measured using self-reported questionnaire
Health Economics 2 Years Health economic assessment of cost-effectiveness
Quality of Life (EQ-5D-5L) 2 Years Quality of life measured using EQ-5D-5L instrument
Cardiovascular Events 5 Years Number of participants who have fatal and non-fatal myocardial infarction or stroke
Cardiovascular Procedures 5 Years Number of Invasive coronary angiography and coronary revascularisation procedures
Death 5 Years Number of all-cause, cardiovascular, coronary heart disease and non-cardiovascular deaths
Cholesterol 5 Years Serum cholesterol concentration
Disadvantages of CTCA- Radiation 5 Years Radiation dose (mGy-cm)
Disadvantages of CTCA- incidental findings 5 Years Number of participants with incidental findings from CTCA
Trial Locations
- Locations (1)
Western General Hospital
🇬🇧Edinburgh, City Of Edinburgh, United Kingdom