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

• ClinicalTrials.gov Identifier: NCT03920176
• Recruitment Status: Recruiting
• First Posted: April 18, 2019
• Last Update Posted: April 5, 2022
• Sponsor: University of Edinburgh
• Collaborators: British Heart Foundation; NHS Lothian
• Information provided by (Responsible Party): University of Edinburgh

Tracking Information

• First Submitted Date: April 16, 2019
• First Posted Date: April 18, 2019
• Last Update Posted Date: April 5, 2022
• Actual Study Start Date: January 13, 2020
• Estimated Primary Completion Date: October 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 17, 2019)

Coronary heart disease death or non-fatal myocardial infarction [ 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 17, 2019)

• Death [ Time Frame: 5 Years ]
  Number of all-cause, cardiovascular, coronary heart disease and non-cardiovascular deaths
• Cardiovascular Events [ Time Frame: 5 Years ]
  Number of participants who have fatal and non-fatal myocardial infarction or stroke
• Cardiovascular Procedures [ Time Frame: 5 Years ]
  Number of Invasive coronary angiography and coronary revascularisation procedures
• Quality of Life (EQ-5D-5L) [ Time Frame: 2 Years ]
  Quality of life measured using EQ-5D-5L instrument
• Prescription [ Time Frame: 5 Years ]
  Rates of prescription of preventative therapies (anti-platelet, statin and angiotensin-converting enzyme inhibitor therapies)
• Lifestyle Modification [ Time Frame: 2 Years ]
  Uptake of lifestyle modifications (smoking, exercise and diet) measured using self-reported questionnaire
• Health Economics [ Time Frame: 2 Years ]
  Health economic assessment of cost-effectiveness
• Cholesterol [ Time Frame: 5 Years ]
  Serum cholesterol concentration
• Disadvantages of CTCA- Radiation [ Time Frame: 5 Years ]
  Radiation dose (mGy-cm)
• Disadvantages of CTCA- incidental findings [ Time Frame: 5 Years ]
  Number of participants with incidental findings from CTCA

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Condition: Cardiovascular Diseases

Intervention

• Diagnostic Test: Computed tomography coronary angiography
  CTCA >64 detector row scanner
• Other: ASSIGN Score
  ASSIGN Cardiovascular Risk Score

Study Arms

• Active Comparator: Computed tomography coronary angiography
  Interventions:

  • Diagnostic Test: Computed tomography coronary angiography
  • Other: ASSIGN Score
• Sham Comparator: Assign Score only
  Intervention: Other: ASSIGN Score

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 17, 2019): 6000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 1, 2027
• Estimated Primary Completion Date: October 1, 2023 (Final data collection date for primary outcome measure)

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 (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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: David E Newby; 01312426515; d.e.newby@ed.ac.uk

Contact: Trial Manager; 0131 651 9901; scot.heart2@ed.ac.uk

• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03920176
• Other Study ID Numbers: IRAS ID: 261185
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The intention is to share anonymised data with external collaborators and scientists. The data will be available one year after the primary paper has been published (anticipated to be in 2027) .
• Supporting Materials: Study Protocol
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: After 2027.
• Access Criteria: Requests can be made by email from 2027.

• Current Responsible Party: University of Edinburgh
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Edinburgh
• Original Study Sponsor: Same as current

Collaborators

• British Heart Foundation
• NHS Lothian

Investigators

• Principal Investigator: David E Newby; University of Edinburgh

• PRS Account: University of Edinburgh
• Verification Date: March 2022