Troponin to Risk Stratify Patients for Computed Tomography Coronary Angiography
NCT ID: NCT04549805
Last Updated: 2021-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2018-12-04
2020-10-06
Brief Summary
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This study will use a heart scan known as computed tomography coronary angiogram (CTCA) to look for underlying coronary heart disease in patients who have had a heart attack ruled out. In an earlier study, we performed this scan in patients referred to the outpatient cardiology clinic with stable chest pain and found that this improved the diagnosis of coronary heart disease, leading to improvement in patient care that prevented many future heart attacks. Our research has also demonstrated that troponin levels below the threshold used to diagnose a heart attack identify those who are at greater risk of having a heart attack in the future. The aim of this study is to confirm whether these low levels of troponin can identify patients who have underlying coronary heart disease and may benefit from further testing and preventative treatment.
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Detailed Description
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The investigators will evaluate consecutive patients presenting to hospital with suspected acute coronary syndrome and cardiac troponin concentration within the normal reference range for the presence of underlying coronary artery disease. All participants will be invited for an outpatient CTCA.
Findings from this study will help inform a randomised controlled trial to evaluate the role of CTCA in patients who have a heart attack ruled out, but are identified as intermediate risk on troponin testing.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Patients without myocardial injury
Patients without myocardial injury will be recruited in a 2:1 fashion stratified by peak high-sensitivity cardiac troponin I concentration above and below a threshold of 5 ng/L.
Computed Tomography Coronary Angiography
In order to optimise the quality of the Computed Tomography Coronary Angiography scan images, participants might be given tablets or an injection (e.g. beta-blockers, calcium channel antagonist, ivabradine) to slow their heart rate and glyceryl trinitrate (GTN) following local protocol guidance.
Interventions
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Computed Tomography Coronary Angiography
In order to optimise the quality of the Computed Tomography Coronary Angiography scan images, participants might be given tablets or an injection (e.g. beta-blockers, calcium channel antagonist, ivabradine) to slow their heart rate and glyceryl trinitrate (GTN) following local protocol guidance.
Eligibility Criteria
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Inclusion Criteria
* Maximum high-sensitivity cardiac troponin I concentration below the 99th centile (16 ng/L for women and 34 ng/L in men)
Exclusion Criteria
* Clear alternative diagnosis for index presentation
* Recent CT or invasive coronary angiogram (within 1 year)
* Patient inability to undergo CT scanning, due to severe renal failure (estimated glomerular filtration rate \<30 mL/min) or major allergy to iodinated contrast media
* Pregnancy or breast feeding
* Inability to give informed consent
* Further investigation for coronary artery disease would not in the patient's interest, due to limited life expectancy, quality of life or functional status
30 Years
ALL
No
Sponsors
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NHS Lothian
OTHER_GOV
British Heart Foundation
OTHER
University of Edinburgh
OTHER
Responsible Party
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Locations
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Centre for Cardiovascular Science, University of Edinburgh
Edinburgh, , United Kingdom
Countries
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References
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Perez-Vicencio D, Thurston AJF, Doudesis D, O'Brien R, Ferry A, Fujisawa T, Williams MC, Gray AJ, Mills NL, Lee KK. Risk scores and coronary artery disease in patients with suspected acute coronary syndrome and intermediate cardiac troponin concentrations. Open Heart. 2024 Aug 3;11(2):e002755. doi: 10.1136/openhrt-2024-002755.
Other Identifiers
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245971
Identifier Type: -
Identifier Source: org_study_id
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