Western General Hospital
Edinburgh, City Of Edinburgh, EH4 2XU, United Kingdom
NCT Number: NCT03920176
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.
This study is active but is not currently recruiting participants.
Notify Me40 year–70 year
All sexes
Interventional
Not applicable
Edinburgh, City Of Edinburgh, EH4 2XU, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CTCA >64 detector row scanner
ASSIGN Cardiovascular Risk Score
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.
Time frame: 5 Years
Number of all-cause, cardiovascular, coronary heart disease and non-cardiovascular deaths
Time frame: 5 Years
Number of participants who have fatal and non-fatal myocardial infarction or stroke
Time frame: 5 Years
Number of Invasive coronary angiography and coronary revascularisation procedures
Time frame: 2 Years
Quality of life measured using EQ-5D-5L instrument
Time frame: 5 Years
Rates of prescription of preventative therapies (anti-platelet, statin and angiotensin-converting enzyme inhibitor therapies)
Time frame: 2 Years
Uptake of lifestyle modifications (smoking, exercise and diet) measured using self-reported questionnaire
Time frame: 2 Years
Health economic assessment of cost-effectiveness
Time frame: 5 Years
Serum cholesterol concentration
Time frame: 5 Years
Radiation dose (mGy-cm)
Time frame: 5 Years
Number of participants with incidental findings from CTCA
University of Edinburgh
Other
Acronym: SCOT-HEART 2
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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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