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
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Computed tomography coronary angiography | CTCA \>64 detector row scanner |
| OTHER | ASSIGN Score | ASSIGN 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.