Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography (TARGET-CTCA)
Primary Purpose
Coronary Artery Disease
Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CT Coronary Angiography (CTCA)
Sponsored by
About this trial
This is an interventional screening trial for Coronary Artery Disease
Eligibility 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
Sites / Locations
- NHS Lothian
- NHS Greater Glasgow and Clyde
- Lewisham & Greenwich NHS Trust
- Milton Keynes University NHS Hospital
- University Hospitals Plymouth NHS Trust
- Royal Berkshire NHS Foundation Trust
- University Hospital Southampton NHS Trust
- North Tees NHS Hospital Foundation
- Torbay & South Devon NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CTCA with standard care
Standard care
Arm Description
Patients will be referred for CT Coronary Angiography, ideally within 2 weeks of randomisation
Outcomes
Primary Outcome Measures
Composite of myocardial infarction or cardiac death
The first event of myocardial infarction or cardiac death
Secondary Outcome Measures
Myocardial Infarction
The first event of myocardial infarction (MI). MI will be defined according to the 4th Universal Definition of Myocardial Infarction
Cardiac death
Cardiac death will be defined as death resulting from an acute myocardial infarction, sudden cardiac death, or death due to heart failure.
Cardiovascular death
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
All-cause death
Unscheduled urgent coronary revascularisation
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
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)
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)
Quality of life as assessed by the EQ-5D-5L
Full Information
NCT ID
NCT03952351
First Posted
May 14, 2019
Last Updated
May 29, 2023
Sponsor
University of Edinburgh
Collaborators
British Heart Foundation, University of Sheffield, NHS Lothian, NHS Greater Glasgow and Clyde
1. Study Identification
Unique Protocol Identification Number
NCT03952351
Brief Title
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Acronym
TARGET-CTCA
Official Title
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
British Heart Foundation, University of Sheffield, NHS Lothian, NHS Greater Glasgow and Clyde
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CTCA with standard care
Arm Type
Experimental
Arm Description
Patients will be referred for CT Coronary Angiography, ideally within 2 weeks of randomisation
Arm Title
Standard care
Arm Type
No Intervention
Intervention Type
Radiation
Intervention Name(s)
CT Coronary Angiography (CTCA)
Intervention Description
CTCA scan in accordance with British Society of Cardiovascular Imaging CT guidelines
Primary Outcome Measure Information:
Title
Composite of myocardial infarction or cardiac death
Description
The first event of myocardial infarction or cardiac death
Time Frame
Randomisation through to study completion, median duration of 36 months
Secondary Outcome Measure Information:
Title
Myocardial Infarction
Description
The first event of myocardial infarction (MI). MI will be defined according to the 4th Universal Definition of Myocardial Infarction
Time Frame
Randomisation through to study completion, median duration of 36 months
Title
Cardiac death
Description
Cardiac death will be defined as death resulting from an acute myocardial infarction, sudden cardiac death, or death due to heart failure.
Time Frame
Randomisation through to study completion, median duration of 36 months
Title
Cardiovascular death
Description
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
Time Frame
Randomisation through to study completion, median duration of 36 months
Title
Non-cardiovascular death
Time Frame
Randomisation through to study completion, median duration of 36 months
Title
All-cause death
Time Frame
Randomisation through to study completion, median duration of 36 months
Title
Unscheduled urgent coronary revascularisation
Description
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.
Time Frame
Randomisation through to study completion, median duration of 36 months
Title
Hospital reattendance with suspected ACS
Description
Reattendance with suspected ACS will be defined as any unscheduled hospital attendance where cardiac troponin testing is performed for suspected ACS following randomisation
Time Frame
Randomisation through to study completion, median duration of 36 months
Title
Proportion of patients with major bleeding (BARC 3-5)
Description
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.
Time Frame
Randomisation through to study completion, median duration of 36 months
Title
Symptomatic status as assessed by the short form Seattle Angina Questionnaire (SAQ-7)
Time Frame
3, 12 and 24 months
Title
Quality of life as assessed by the EQ-5D-5L
Time Frame
3, 12 and 24 months
Other Pre-specified Outcome Measures:
Title
Proportion of patients with allergy/anaphylaxis/acute kidney injury following study CTCA scan
Time Frame
2 weeks
Title
Proportion of patients undergoing non-study CTCA or invasive coronary angiography (ICA)
Time Frame
90 days
Title
Proportion of patients with clinically significant abnormal non-cardiac findings on study CTCA scan
Time Frame
2 weeks
Title
Dose length product from study CTCA scan
Time Frame
2 weeks
Title
Proportion of patients undergoing non-invasive stress test (cost-effectiveness)
Time Frame
90 days
Title
Proportion of patients prescribed therapies for coronary artery disease (cost-effectiveness)
Time Frame
Randomisation through to study completion, median duration of 36 months
Title
Proportion of patients undergoing planned revascularisation (cost-effectiveness)
Time Frame
Randomisation through to study completion, median duration of 36 months
Title
Incremental cost per quality-adjusted life year (QALY) gained (cost-effectiveness)
Time Frame
Randomisation through to study completion, median duration of 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
NHS Lothian
City
Edinburgh
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
Country
United Kingdom
Facility Name
Lewisham & Greenwich NHS Trust
City
London
Country
United Kingdom
Facility Name
Milton Keynes University NHS Hospital
City
Milton Keynes
Country
United Kingdom
Facility Name
University Hospitals Plymouth NHS Trust
City
Plymouth
Country
United Kingdom
Facility Name
Royal Berkshire NHS Foundation Trust
City
Reading
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Trust
City
Southampton
Country
United Kingdom
Facility Name
North Tees NHS Hospital Foundation
City
Stockton
Country
United Kingdom
Facility Name
Torbay & South Devon NHS Foundation Trust
City
Torquay
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Following publication of the primary paper, a deidentified individual participant data set will be will be made available for data sharing purposes, subject to necessary governance approvals. Access to the deidentified dataset will be under a controlled access model.
Learn more about this trial
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
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