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出境医 / 临床实验 / Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography (TARGET-CTCA)
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography (TARGET-CTCA)
Study Description
Brief Summary:
Most patients presenting to hospital with symptoms of a heart attack are sent 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 heart disease and are at risk of having a heart attack in the future. However, clinicians 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 unrecognised heart disease in patients who have had a heart attack ruled out. In an earlier study, the Investigators performed this scan in patients referred to the outpatient cardiology clinic with stable chest pain and found that this improved the diagnosis of heart disease, leading to improvement in patient care that prevented future heart attacks.
Previous research from the Investigators has also found that troponin levels below those used to diagnose a heart attack may help to identify those who are at greater risk of having a heart attack in the future.
The aim of this study is to find out if patients with these low levels of troponin, where a heart attack has been ruled out, will benefit from CTCA to look for unrecognised coronary heart disease.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Artery Disease | Radiation: CT Coronary Angiography (CTCA) | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 2270 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Screening |
| Official Title: | Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography |
| Actual Study Start Date : | September 18, 2019 |
| Estimated Primary Completion Date : | November 2023 |
| Estimated Study Completion Date : | November 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: CTCA with standard care
Patients will be referred for CT Coronary Angiography, ideally within 2 weeks of randomisation
|
Radiation: CT Coronary Angiography (CTCA)
CTCA scan in accordance with British Society of Cardiovascular Imaging CT guidelines
|
| No Intervention: Standard care |
Outcome Measures
Primary Outcome Measures :
- Composite of myocardial infarction or cardiac death [ Time Frame: Randomisation through to study completion, median duration of 36 months ]The first event of myocardial infarction or cardiac death
Secondary Outcome Measures :
- Myocardial Infarction [ Time Frame: Randomisation through to study completion, median duration of 36 months ]The first event of myocardial infarction (MI). MI will be defined according to the 4th Universal Definition of Myocardial Infarction
- Cardiac death [ Time Frame: Randomisation through to study completion, median duration of 36 months ]Cardiac death will be defined as death resulting from an acute myocardial infarction, sudden cardiac death, or death due to heart failure.
- Cardiovascular death [ Time Frame: Randomisation through to study completion, median duration of 36 months ]Cardiovascular death will be defined as death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular haemorrhage, and death due to other cardiovascular causes
- Non-cardiovascular death [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
- All-cause death [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
- Unscheduled urgent coronary revascularisation [ Time Frame: Randomisation through to study completion, median duration of 36 months ]Unscheduled urgent coronary revascularisation will be identified via record linkage from central NHS registers (e.g. the Scottish Morbidity Register by the Information Services Division (ISD) Scotland) or from extracts obtained from the participating hospitals electronic patient record system.
- Hospital reattendance with suspected ACS [ Time Frame: Randomisation through to study completion, median duration of 36 months ]Reattendance with suspected ACS will be defined as any unscheduled hospital attendance where cardiac troponin testing is performed for suspected ACS following randomisation
- Proportion of patients with major bleeding (BARC 3-5) [ Time Frame: Randomisation through to study completion, median duration of 36 months ]Bleeding will be defined according to the Bleeding Academic Research Consortium (BARC) definition of bleeding. We will use pre-defined codes from International Classification of Diseases (ICD-10) and Office of Population Censuses and Surveys (OPCS) to classify each bleeding event as per the BARC definition.
- Symptomatic status as assessed by the short form Seattle Angina Questionnaire (SAQ-7) [ Time Frame: 3, 12 and 24 months ]
- Quality of life as assessed by the EQ-5D-5L [ Time Frame: 3, 12 and 24 months ]
Other Outcome Measures:
- Proportion of patients with allergy/anaphylaxis/acute kidney injury following study CTCA scan [ Time Frame: 2 weeks ]
- Proportion of patients undergoing non-study CTCA or invasive coronary angiography (ICA) [ Time Frame: 90 days ]
- Proportion of patients with clinically significant abnormal non-cardiac findings on study CTCA scan [ Time Frame: 2 weeks ]
- Dose length product from study CTCA scan [ Time Frame: 2 weeks ]
- Proportion of patients undergoing non-invasive stress test (cost-effectiveness) [ Time Frame: 90 days ]
- Proportion of patients prescribed therapies for coronary artery disease (cost-effectiveness) [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
- Proportion of patients undergoing planned revascularisation (cost-effectiveness) [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
- Incremental cost per quality-adjusted life year (QALY) gained (cost-effectiveness) [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Presenting to hospital with symptoms of suspected acute coronary syndrome
- Age 18 years and over
- Maximum high-sensitivity cardiac troponin concentration between 5ng/L and the 99th percentile
Exclusion Criteria:
- Diagnosis of myocardial infarction during index presentation
- Clear alternative diagnosis or participant requires further inpatient clinical assessment
- Recent CTCA or invasive coronary angiogram (within 1 year)
- Patient inability to undergo CT scanning, e.g. due to severe renal failure (estimated glomerular filtration rate <30 mL/min) or major allergy to iodinated contrast media
- Current pregnancy or breast feeding
- Inability to give informed consent
- Further investigation for coronary artery disease would not be in the patient's interest, e.g. due to limited life expectancy, quality of life or functional status
- Previous randomisation into the trial
Contacts and Locations
Contacts
| Contact: TARGET-CTCA Trial Manager | 00 44 131 6519907 | Target.CTCA@ed.ac.uk |
Locations
| United Kingdom | |
| NHS Lothian | Recruiting |
| Edinburgh, United Kingdom | |
| NHS Greater Glasgow and Clyde | Not yet recruiting |
| Glasgow, United Kingdom | |
Sponsors and Collaborators
University of Edinburgh
British Heart Foundation
University of Sheffield
NHS Lothian
NHS Greater Glasgow and Clyde
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 14, 2019 | ||||
| First Posted Date ICMJE | May 16, 2019 | ||||
| Last Update Posted Date | April 28, 2021 | ||||
| Actual Study Start Date ICMJE | September 18, 2019 | ||||
| Estimated Primary Completion Date | November 2023 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Composite of myocardial infarction or cardiac death [ Time Frame: Randomisation through to study completion, median duration of 36 months ] The first event of myocardial infarction or cardiac death
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography | ||||
| Official Title ICMJE | Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography | ||||
| Brief Summary |
Most patients presenting to hospital with symptoms of a heart attack are sent 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 heart disease and are at risk of having a heart attack in the future. However, clinicians 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 unrecognised heart disease in patients who have had a heart attack ruled out. In an earlier study, the Investigators performed this scan in patients referred to the outpatient cardiology clinic with stable chest pain and found that this improved the diagnosis of heart disease, leading to improvement in patient care that prevented future heart attacks. Previous research from the Investigators has also found that troponin levels below those used to diagnose a heart attack may help to identify those who are at greater risk of having a heart attack in the future. The aim of this study is to find out if patients with these low levels of troponin, where a heart attack has been ruled out, will benefit from CTCA to look for unrecognised coronary heart disease. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Screening |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Radiation: CT Coronary Angiography (CTCA)
CTCA scan in accordance with British Society of Cardiovascular Imaging CT guidelines
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
2270 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | November 2023 | ||||
| Estimated Primary Completion Date | November 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03952351 | ||||
| Other Study ID Numbers ICMJE | AC18106 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Edinburgh | ||||
| Study Sponsor ICMJE | University of Edinburgh | ||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||
| PRS Account | University of Edinburgh | ||||
| Verification Date | April 2021 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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