Coronary Artery DiseasePRECISE-CTCANCT04549805
Troponin to Risk Stratify Patients for Computed Tomography Coronary Angiography
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Most patients presenting to hospital with chest pain are discharged home without further tests once a heart attack has been ruled out. Current strategies to assess patients with a suspected heart attack involve blood tests to measure troponin, a protein released into the bloodstream when the heart muscle is damaged. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- Computed Tomography Coronary Angiography
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Dec 2018to 6 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (30 years and over) with acute chest pain or equivalent symptoms of suspected acute coronary syndrome and maximum high-sensitivity cardiac troponin I concentration below the 99th centile (16 ng/L for women and 34 ng/L in men)
Who may be able to join
- Presentation to hospital with acute chest pain or equivalent symptoms of suspected acute coronary syndrome
- Maximum high-sensitivity cardiac troponin I concentration below the 99th centile (16 ng/L for women and 34 ng/L in men)
Who cannot join
- Diagnosis of myocardial infarction during index presentation
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Cardiovascular Science, University of Edinburgh
Edinburgh, EH16 4SB
About this study
Official title: Troponin Within the Normal Reference Range to Risk Stratify Patients With Acute Chest Pain for Computed Tomography Coronary Angiography
Most patients presenting to hospital with chest pain are discharged home without further tests once a heart attack has been ruled out. Current strategies to assess patients with a suspected heart attack involve blood tests to measure troponin, a protein released into the bloodstream when the heart muscle is damaged. Despite having had a heart attack ruled-out, some patients have unrecognised coronary heart disease and are at risk of having a heart attack in the future. However, we do not know what is the best approach to identify and treat these patients.
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.
Read the detailed description
Using a newer, more sensitive troponin test, we now know that troponin levels even below the threshold used to diagnose a heart attack identify patients who are at risk of having a heart attack in the future. Our research in patients with stable chest pain demonstrated that computed tomography coronary angiogram (CTCA) improved the diagnosis of coronary heart disease, leading to improvement in patient care that prevented many future heart attacks. This study will build on these two major strands of research 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.
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
- Coronary Artery Disease, Acute Coronary Syndrome
- Being tested
- Computed Tomography Coronary Angiography
- Keywords
- Coronary artery disease, CT coronary angiography, High-sensitivity cardiac troponin
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography Coronary AngiographyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Computed Tomography Coronary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with obstructive coronary artery disease
Proportion of participants with >50% stenosis in the left main stem or >70% stenosis in other coronary arteries
Measured: Ideally within 4 weeks of index presentation
Secondary outcomes (4)
Proportion of participants with moderate non-obstructive coronary artery disease
Proportion of participants with 50-70% stenosis in one or more coronary arteries
Measured: Ideally within 4 weeks of index presentation
Proportion of participants with mild non-obstructive coronary artery disease
Proportion of participants with 10-50% stenosis in one or more coronary arteries
Measured: Ideally within 4 weeks of index presentation
Proportion of participants with insignificant coronary artery disease
Proportion of participants with 1-10% stenosis in one or more coronary arteries
Measured: Ideally within 4 weeks of index presentation
Proportion of participants with normal coronary arteries
Proportion of participants with no stenosis in coronary arteries
Measured: Ideally within 4 weeks of index presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start4 Dec 2018
- Primary completion6 Oct 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, British Heart Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549805
- Sponsor's protocol ID
- 245971
- Acronym
- PRECISE-CTCA
- Status last verified
- Mar 2021
- First submitted
- 31 Aug 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Requests for IPD will be considered on an individual basis.
Publications
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.
PubMed 39097328
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Troponin Within the Normal Reference Range to Risk Stratify Patients With Acute Chest Pain for Computed Tomography Coronary Angiography
- ClinicalTrials.gov ID
- NCT04549805
- Acronym / sponsor ID
- PRECISE-CTCA / 245971
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Keywords
- Coronary artery disease, CT coronary angiography, High-sensitivity cardiac troponin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian, British Heart Foundation
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most patients presenting to hospital with chest pain are discharged home without further tests once a heart attack has been ruled out. Current strategies to assess patients with a suspected heart attack involve blood tests to measure troponin, a protein released into the bloodstream when the heart muscle is damaged. Despite having had a heart attack ruled-out, some patients have unrecognised coronary heart disease and are at risk of having a heart attack in the future. However, we do not know what is the best approach to identify and treat these patients.
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.
Detailed description
Using a newer, more sensitive troponin test, we now know that troponin levels even below the threshold used to diagnose a heart attack identify patients who are at risk of having a heart attack in the future. Our research in patients with stable chest pain demonstrated that computed tomography coronary angiogram (CTCA) improved the diagnosis of coronary heart disease, leading to improvement in patient care that prevented many future heart attacks. This study will build on these two major strands of research 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients without myocardial injury | – | Diagnostic Test: Computed Tomography Coronary AngiographyPatients 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (30 years and over) with acute chest pain or equivalent symptoms of suspected acute coronary syndrome and maximum high-sensitivity cardiac troponin I concentration below the 99th centile (16 ng/L for women and 34 ng/L in men)
Key inclusion criteria (2 listed)
- Presentation to hospital with acute chest pain or equivalent symptoms of suspected acute coronary syndrome
- Maximum high-sensitivity cardiac troponin I concentration below the 99th centile (16 ng/L for women and 34 ng/L in men)
Key exclusion criteria (7 listed)
- Diagnosis of myocardial infarction during index presentation
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed Tomography Coronary AngiographyIn 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. | Diagnostic test | Patients without myocardial injury |
Primary outcome
Proportion of participants with obstructive coronary artery disease
Time frame: Ideally within 4 weeks of index presentation
Proportion of participants with >50% stenosis in the left main stem or >70% stenosis in other coronary arteries
4 secondary outcomes
Proportion of participants with moderate non-obstructive coronary artery disease
Time frame: Ideally within 4 weeks of index presentation
Proportion of participants with mild non-obstructive coronary artery disease
Time frame: Ideally within 4 weeks of index presentation
Proportion of participants with insignificant coronary artery disease
Time frame: Ideally within 4 weeks of index presentation
Proportion of participants with normal coronary arteries
Time frame: Ideally within 4 weeks of index presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 39097328Perez-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.
- Individual participant dataSharing planned: Undecided. Requests for IPD will be considered on an individual basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with obstructive coronary artery disease (time frame: Ideally within 4 weeks of index presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04549805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.