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

Cardiovascular Diseases Clinical Trial

— SCOT-HEART 2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03920176
• Other study ID #: IRAS ID: 261185
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2024
• Source: University of Edinburgh
• Contact: David E Newby
• Phone: 01312426515
• Email: d.e.newby[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• Computed tomography coronary angiography
CTCA >64 detector row scanner

Other:
• ASSIGN Score
ASSIGN Cardiovascular Risk Score

Locations

Country	Name	City	State
United Kingdom	Western General Hospital	Edinburgh	City Of Edinburgh

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	British Heart Foundation, NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

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

External Links

•   Study website