Clinical trial NCT03920176: Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
Official title: Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Cardiology
Computed tomography coronary angiography
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: NHS Lothian
First posted: 2019-04-18
Enrollment: 6000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 or 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.
* Previous coronary artery imaging completed specifically for cardiovascular risk assessment with a result of \>10 AU.

Primary outcomes:
measure: Coronary heart disease death or non-fatal myocardial infarction
timeFrame: 5 years
Secondary outcomes:
measure: Death
timeFrame: 5 Years
measure: Cardiovascular Events
timeFrame: 5 Years
measure: Cardiovascular Procedures
timeFrame: 5 Years
measure: Quality of Life (EQ-5D-5L)
timeFrame: 2 Years
measure: Prescription
timeFrame: 5 Years
measure: Lifestyle Modification
timeFrame: 2 Years
measure: Health Economics
timeFrame: 2 Years
measure: Cholesterol
timeFrame: 5 Years
measure: Disadvantages of CTCA- Radiation
timeFrame: 5 Years
measure: Disadvantages of CTCA- incidental findings
timeFrame: 5 Years
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: City Of Edinburgh
Study officials:
affiliation: University of Edinburgh
name: David E Newby
role: PRINCIPAL_INVESTIGATOR
References: