Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography (TARGET-CTCA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Radiation: CT Coronary Angiography (CTCA)

• Study Type: Interventional
• Enrollment (Actual): 3170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: TARGET-CTCA Trial Manager; Phone Number: 00 44 131 6519907; Email: Target.CTCA@ed.ac.uk

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • NHS Lothian
  • Glasgow, United Kingdom
    • NHS Greater Glasgow and Clyde
  • London, United Kingdom
    • Lewisham & Greenwich NHS Trust
  • Milton Keynes, United Kingdom
    • Milton Keynes University NHS Hospital
  • Plymouth, United Kingdom
    • University Hospitals Plymouth NHS Trust
  • Reading, United Kingdom
    • Royal Berkshire NHS foundation trust
  • Southampton, United Kingdom
    • University Hospital Southampton NHS Trust
  • Stockton, United Kingdom
    • North Tees NHS Hospital Foundation
  • Torquay, United Kingdom
    • Torbay & South Devon NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of myocardial infarction or cardiac death	The first event of myocardial infarction or cardiac death	Randomisation through to study completion, median duration of 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial Infarction	The first event of myocardial infarction (MI). MI will be defined according to the 4th Universal Definition of Myocardial Infarction	Randomisation through to study completion, median duration of 36 months
Cardiac death	Cardiac death will be defined as death resulting from an acute myocardial infarction, sudden cardiac death, or death due to heart failure.	Randomisation through to study completion, median duration of 36 months
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	Randomisation through to study completion, median duration of 36 months
Non-cardiovascular death		Randomisation through to study completion, median duration of 36 months
All-cause death		Randomisation through to study completion, median duration of 36 months
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.	Randomisation through to study completion, median duration of 36 months
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	Randomisation through to study completion, median duration of 36 months
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.	Randomisation through to study completion, median duration of 36 months
Symptomatic status as assessed by the short form Seattle Angina Questionnaire (SAQ-7)		3, 12 and 24 months
Quality of life as assessed by the EQ-5D-5L		3, 12 and 24 months

Other Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with allergy/anaphylaxis/acute kidney injury following study CTCA scan	2 weeks
Proportion of patients undergoing non-study CTCA or invasive coronary angiography (ICA)	90 days
Proportion of patients with clinically significant abnormal non-cardiac findings on study CTCA scan	2 weeks
Dose length product from study CTCA scan	2 weeks
Proportion of patients undergoing non-invasive stress test (cost-effectiveness)	90 days
Proportion of patients prescribed therapies for coronary artery disease (cost-effectiveness)	Randomisation through to study completion, median duration of 36 months
Proportion of patients undergoing planned revascularisation (cost-effectiveness)	Randomisation through to study completion, median duration of 36 months
Incremental cost per quality-adjusted life year (QALY) gained (cost-effectiveness)	Randomisation through to study completion, median duration of 36 months

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: University of Sheffield; NHS Lothian; British Heart Foundation; NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2019
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Coronary Artery Disease; Chest Pain
• Other Study ID Numbers: AC18106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No