NCT03952351

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,170

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

May 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
6.7 years until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2026

Expected
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

May 14, 2019

Last Update Submit

April 16, 2026

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Myocardial Infarction

    Randomisation through to study completion, median duration of 36 months

  • Cardiac death

    Randomisation through to study completion, median duration of 36 months

  • Cardiovascular death

    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

  • +5 more secondary outcomes

Other Outcomes (8)

  • 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

  • +5 more other outcomes

Study Arms (2)

CTCA with standard care

EXPERIMENTAL

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

Radiation: CT Coronary Angiography (CTCA)

Standard care

NO INTERVENTION

Interventions

CT Coronary Angiography (CTCA)RADIATION

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

CTCA with standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

NHS Lothian

Edinburgh, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

Lewisham & Greenwich NHS Trust

London, United Kingdom

Location

Milton Keynes University NHS Hospital

Milton Keynes, United Kingdom

Location

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Location

Royal Berkshire NHS Foundation Trust

Reading, United Kingdom

Location

University Hospital Southampton NHS Trust

Southampton, United Kingdom

Location

North Tees NHS Hospital Foundation

Stockton, United Kingdom

Location

Torbay & South Devon NHS Foundation Trust

Torquay, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 37312104DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 16, 2019

Study Start

January 31, 2026

Primary Completion

March 31, 2026

Study Completion (Estimated)

August 28, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Locations

GB(9)