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

NCT ID: NCT03952351

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

3170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-18

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CTCA with standard care

Patients will be referred for CT Coronary Angiography, ideally within 2 weeks of randomisation

Group Type EXPERIMENTAL

CT Coronary Angiography (CTCA)

Intervention Type RADIATION

CTCA scan in accordance with British Society of Cardiovascular Imaging CT guidelines

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CT Coronary Angiography (CTCA)

CTCA scan in accordance with British Society of Cardiovascular Imaging CT guidelines

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Heart Foundation

OTHER

Sponsor Role collaborator

University of Sheffield

OTHER

Sponsor Role collaborator

NHS Lothian

OTHER_GOV

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NHS Lothian

Edinburgh, , United Kingdom

Site Status

NHS Greater Glasgow and Clyde

Glasgow, , United Kingdom

Site Status

Lewisham & Greenwich NHS Trust

London, , United Kingdom

Site Status

Milton Keynes University NHS Hospital

Milton Keynes, , United Kingdom

Site Status

University Hospitals Plymouth NHS Trust

Plymouth, , United Kingdom

Site Status

Royal Berkshire NHS Foundation Trust

Reading, , United Kingdom

Site Status

University Hospital Southampton NHS Trust

Southampton, , United Kingdom

Site Status

North Tees NHS Hospital Foundation

Stockton, , United Kingdom

Site Status

Torbay & South Devon NHS Foundation Trust

Torquay, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Lee KK, Lowe D, O'Brien R, Wereski R, Bularga A, Taggart C, Lowry MTH, Ferry AV, Williams MC, Roditi G, Byrne J, Tuck C, Cranley D, Thokala P, Goodacre S, Keerie C, Norrie J, Newby DE, Gray AJ, Mills NL. Troponin in acute chest pain to risk stratify and guide effective use of computed tomography coronary angiography (TARGET-CTCA): a randomised controlled trial. Trials. 2023 Jun 13;24(1):402. doi: 10.1186/s13063-023-07431-9.

Reference Type DERIVED
PMID: 37312104 (View on PubMed)

Other Identifiers

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AC18106

Identifier Type: -

Identifier Source: org_study_id

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