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Trials / Active Not Recruiting

Active Not RecruitingNCT03920176

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
6,139 (actual)
Sponsor
University of Edinburgh · Academic / Other
Sex
All
Age
40 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTComputed tomography coronary angiographyCTCA \>64 detector row scanner
OTHERASSIGN ScoreASSIGN Cardiovascular Risk Score

Timeline

Start date
2020-01-13
Primary completion
2025-12-19
Completion
2028-12-31
First posted
2019-04-18
Last updated
2026-01-15

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03920176. Inclusion in this directory is not an endorsement.