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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
| NHS Lothian | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computed tomography coronary angiography | Active Comparator |
| |
| Assign Score only | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed tomography coronary angiography | Diagnostic Test | CTCA >64 detector row scanner |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Number of all-cause, cardiovascular, coronary heart disease and non-cardiovascular deaths | 5 Years |
| Cardiovascular Events | Number of participants who have fatal and non-fatal myocardial infarction or stroke |
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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:
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| David E Newby | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western General Hospital | Edinburgh | City Of Edinburgh | EH4 2XU | United Kingdom |
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| Label | URL |
|---|---|
| Study website | View source |
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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) .
After 2027.
Requests can be made by email from 2027.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 13, 2023 | May 8, 2024 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ASSIGN Score | Other | ASSIGN Cardiovascular Risk Score |
|
| 5 Years |
| Cardiovascular Procedures | Number of Invasive coronary angiography and coronary revascularisation procedures | 5 Years |
| Quality of Life (EQ-5D-5L) | Quality of life measured using EQ-5D-5L instrument | 2 Years |
| Prescription | Rates of prescription of preventative therapies (anti-platelet, statin and angiotensin-converting enzyme inhibitor therapies) | 5 Years |
| Lifestyle Modification | Uptake of lifestyle modifications (smoking, exercise and diet) measured using self-reported questionnaire | 2 Years |
| Health Economics | Health economic assessment of cost-effectiveness | 2 Years |
| Cholesterol | Serum cholesterol concentration | 5 Years |
| Disadvantages of CTCA- Radiation | Radiation dose (mGy-cm) | 5 Years |
| Disadvantages of CTCA- incidental findings | Number of participants with incidental findings from CTCA | 5 Years |