Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography

Coronary Artery Disease Clinical Trial

— TARGET-CTCA  

Official title:

Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03952351
• Other study ID #: AC18106
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2023
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3170
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain
• Coronary Artery Disease

Intervention

Radiation:
• CT Coronary Angiography (CTCA)
CTCA scan in accordance with British Society of Cardiovascular Imaging CT guidelines

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
University of Edinburgh	British Heart Foundation, NHS Greater Glasgow and Clyde, NHS Lothian, University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients with allergy/anaphylaxis/acute kidney injury following study CTCA scan		2 weeks
Other	Proportion of patients undergoing non-study CTCA or invasive coronary angiography (ICA)		90 days
Other	Proportion of patients with clinically significant abnormal non-cardiac findings on study CTCA scan		2 weeks
Other	Dose length product from study CTCA scan		2 weeks
Other	Proportion of patients undergoing non-invasive stress test (cost-effectiveness)		90 days
Other	Proportion of patients prescribed therapies for coronary artery disease (cost-effectiveness)		Randomisation through to study completion, median duration of 36 months
Other	Proportion of patients undergoing planned revascularisation (cost-effectiveness)		Randomisation through to study completion, median duration of 36 months
Other	Incremental cost per quality-adjusted life year (QALY) gained (cost-effectiveness)		Randomisation through to study completion, median duration of 36 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	Non-cardiovascular death		Randomisation through to study completion, median duration of 36 months
Secondary	All-cause death		Randomisation through to study completion, median duration of 36 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Symptomatic status as assessed by the short form Seattle Angina Questionnaire (SAQ-7)		3, 12 and 24 months
Secondary	Quality of life as assessed by the EQ-5D-5L		3, 12 and 24 months