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NCT Number: NCT04549805

Troponin to Risk Stratify Patients for Computed Tomography Coronary Angiography

Most patients presenting to hospital with chest pain are discharged 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 coronary heart disease and are at risk of having a heart attack in the future. However, we 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 underlying coronary heart disease in patients who have had a heart attack ruled out. In an earlier study, we performed this scan in patients referred to the outpatient cardiology clinic with stable chest pain and found that this improved the diagnosis of coronary heart disease, leading to improvement in patient care that prevented many future heart attacks. Our research has also demonstrated that troponin levels below the threshold used to diagnose a heart attack identify those who are at greater risk of having a heart attack in the future. The aim of this study is to confirm whether these low levels of troponin can identify patients who have underlying coronary heart disease and may benefit from further testing and preventative treatment.

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Key information

Conditions

Coronary Artery Disease Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Cardiovascular Science, University of Edinburgh

Edinburgh, EH16 4SB, United Kingdom

About this study

Using a newer, more sensitive troponin test, we now know that troponin levels even below the threshold used to diagnose a heart attack identify patients who are at risk of having a heart attack in the future. Our research in patients with stable chest pain demonstrated that computed tomography coronary angiogram (CTCA) improved the diagnosis of coronary heart disease, leading to improvement in patient care that prevented many future heart attacks. This study will build on these two major strands of research to confirm whether these low levels of troponin can identify patients who have underlying coronary heart disease and may benefit from further testing and preventative treatment.

The investigators will evaluate consecutive patients presenting to hospital with suspected acute coronary syndrome and cardiac troponin concentration within the normal reference range for the presence of underlying coronary artery disease. All participants will be invited for an outpatient CTCA.

Findings from this study will help inform a randomised controlled trial to evaluate the role of CTCA in patients who have a heart attack ruled out, but are identified as intermediate risk on troponin testing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presentation to hospital with acute chest pain or equivalent symptoms of suspected acute coronary syndrome
  • Maximum high-sensitivity cardiac troponin I concentration below the 99th centile (16 ng/L for women and 34 ng/L in men)

Exclusion criteria

  • Diagnosis of myocardial infarction during index presentation
  • Clear alternative diagnosis for index presentation
  • Recent CT or invasive coronary angiogram (within 1 year)
  • Patient inability to undergo CT scanning, due to severe renal failure (estimated glomerular filtration rate <30 mL/min) or major allergy to iodinated contrast media
  • Pregnancy or breast feeding
  • Inability to give informed consent
  • Further investigation for coronary artery disease would not in the patient's interest, due to limited life expectancy, quality of life or functional status

Treatment and study plan

Computed Tomography Coronary Angiography

Diagnostic Test

In order to optimise the quality of the Computed Tomography Coronary Angiography scan images, participants might be given tablets or an injection (e.g. beta-blockers, calcium channel antagonist, ivabradine) to slow their heart rate and glyceryl trinitrate (GTN) following local protocol guidance.

Primary outcomes

  1. Proportion of participants with obstructive coronary artery disease

    Time frame: Ideally within 4 weeks of index presentation

    Proportion of participants with >50% stenosis in the left main stem or >70% stenosis in other coronary arteries

Secondary outcomes

  1. Proportion of participants with moderate non-obstructive coronary artery disease

    Time frame: Ideally within 4 weeks of index presentation

    Proportion of participants with 50-70% stenosis in one or more coronary arteries

  2. Proportion of participants with mild non-obstructive coronary artery disease

    Time frame: Ideally within 4 weeks of index presentation

    Proportion of participants with 10-50% stenosis in one or more coronary arteries

  3. Proportion of participants with insignificant coronary artery disease

    Time frame: Ideally within 4 weeks of index presentation

    Proportion of participants with 1-10% stenosis in one or more coronary arteries

  4. Proportion of participants with normal coronary arteries

    Time frame: Ideally within 4 weeks of index presentation

    Proportion of participants with no stenosis in coronary arteries

Other outcomes

  1. Leaman score for overall coronary artery disease burden

    Time frame: Ideally within 4 weeks of index presentation

  2. Proportion of participants with adverse coronary artery plaque features

    Time frame: Ideally within 4 weeks of index presentation

  3. Myocardial mass

    Time frame: Ideally within 4 weeks of index presentation

  4. Proportion of participants with hemodynamically significant coronary stenosis on CT-derived fractional flow reserve (CT-FFR)

    Time frame: Ideally within 4 weeks of index presentation

  5. Left ventricular volume

    Time frame: Ideally within 4 weeks of index presentation

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • British Heart Foundation
  • NHS Lothian

Registry information

Official study title

Troponin Within the Normal Reference Range to Risk Stratify Patients With Acute Chest Pain for Computed Tomography Coronary Angiography

Acronym: PRECISE-CTCA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2020
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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