Clinical trial NCT03952351: Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Official title: Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: University of Sheffield
name: NHS Lothian
name: NHS Greater Glasgow and Clyde
First posted: 2019-05-16
Enrollment: 3170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Composite of myocardial infarction or cardiac death
timeFrame: Randomisation through to study completion, median duration of 36 months
Secondary outcomes:
measure: Myocardial Infarction
timeFrame: Randomisation through to study completion, median duration of 36 months
measure: Cardiac death
timeFrame: Randomisation through to study completion, median duration of 36 months
measure: Cardiovascular death
timeFrame: Randomisation through to study completion, median duration of 36 months
measure: Non-cardiovascular death
timeFrame: Randomisation through to study completion, median duration of 36 months
measure: All-cause death
timeFrame: Randomisation through to study completion, median duration of 36 months
measure: Unscheduled urgent coronary revascularisation
timeFrame: Randomisation through to study completion, median duration of 36 months
measure: Hospital reattendance with suspected ACS
timeFrame: Randomisation through to study completion, median duration of 36 months
measure: Proportion of patients with major bleeding (BARC 3-5)
timeFrame: Randomisation through to study completion, median duration of 36 months
measure: Symptomatic status as assessed by the short form Seattle Angina Questionnaire (SAQ-7)
timeFrame: 3, 12 and 24 months
measure: Quality of life as assessed by the EQ-5D-5L
timeFrame: 3, 12 and 24 months
Other outcomes:
measure: Proportion of patients with allergy/anaphylaxis/acute kidney injury following study CTCA scan
timeFrame: 2 weeks
measure: Proportion of patients undergoing non-study CTCA or invasive coronary angiography (ICA)
timeFrame: 90 days
measure: Proportion of patients with clinically significant abnormal non-cardiac findings on study CTCA scan
timeFrame: 2 weeks
measure: Dose length product from study CTCA scan
timeFrame: 2 weeks
measure: Proportion of patients undergoing non-invasive stress test (cost-effectiveness)
timeFrame: 90 days
measure: Proportion of patients prescribed therapies for coronary artery disease (cost-effectiveness)
timeFrame: Randomisation through to study completion, median duration of 36 months
measure: Proportion of patients undergoing planned revascularisation (cost-effectiveness)
timeFrame: Randomisation through to study completion, median duration of 36 months
measure: Incremental cost per quality-adjusted life year (QALY) gained (cost-effectiveness)
timeFrame: Randomisation through to study completion, median duration of 36 months
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: London
country: United Kingdom
facility: Lewisham & Greenwich NHS Trust
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University NHS Hospital
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Trust
city: Stockton
country: United Kingdom
facility: North Tees NHS Hospital Foundation
city: Torquay
country: United Kingdom
facility: Torbay & South Devon NHS Foundation Trust
Study officials:
References: