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

Sponsor

University of Edinburgh (Other)

Overall Status

Recruiting

CT.gov ID

NCT03920176

Collaborator

British Heart Foundation (Other), NHS Lothian (Other)

6,000

Enrollment

Location

Arms

86.6

Anticipated Duration (Months)

69.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Diagnostic Test: Computed tomography coronary angiography Other: ASSIGN Score	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

6000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 13, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Computed tomography coronary angiography	Diagnostic Test: Computed tomography coronary angiography CTCA >64 detector row scanner Other: ASSIGN Score ASSIGN Cardiovascular Risk Score
Sham Comparator: Assign Score only	Other: ASSIGN Score ASSIGN Cardiovascular Risk Score

Arm

Intervention/Treatment

Active Comparator: Computed tomography coronary angiography

Diagnostic Test: Computed tomography coronary angiography

CTCA >64 detector row scanner

Other: ASSIGN Score

ASSIGN Cardiovascular Risk Score

Sham Comparator: Assign Score only

Other: ASSIGN Score

ASSIGN Cardiovascular Risk Score

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.