Troponin to Risk Stratify Patients for Computed Tomography Coronary Angiography

NCT04549805 | Completed

• 1 other identifier: 245971
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Keywords

Coronary artery disease; CT coronary angiography; High-sensitivity cardiac troponin

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with obstructive coronary artery disease

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

  Ideally within 4 weeks of index presentation

Secondary Outcomes (4)

• Proportion of participants with moderate non-obstructive coronary artery disease

  Ideally within 4 weeks of index presentation

• Proportion of participants with mild non-obstructive coronary artery disease

  Ideally within 4 weeks of index presentation

• Proportion of participants with insignificant coronary artery disease

  Ideally within 4 weeks of index presentation

• Proportion of participants with normal coronary arteries

  Ideally within 4 weeks of index presentation

Other Outcomes (5)

• Leaman score for overall coronary artery disease burden

  Ideally within 4 weeks of index presentation

• Proportion of participants with adverse coronary artery plaque features

  Ideally within 4 weeks of index presentation

• Myocardial mass

  Ideally within 4 weeks of index presentation

Study Arms (1)

Patients without myocardial injury

Patients without myocardial injury will be recruited in a 2:1 fashion stratified by peak high-sensitivity cardiac troponin I concentration above and below a threshold of 5 ng/L.

Diagnostic Test: Computed Tomography Coronary Angiography

Interventions

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.

Patients without myocardial injury

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (30 years and over) with acute chest pain or equivalent symptoms of suspected acute coronary syndrome and maximum high-sensitivity cardiac troponin I concentration below the 99th centile (16 ng/L for women and 34 ng/L in men)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

Centre for Cardiovascular Science, University of Edinburgh

Edinburgh, EH16 4SB, United Kingdom

Location

Related Publications (1)

• Perez-Vicencio D, Thurston AJF, Doudesis D, O'Brien R, Ferry A, Fujisawa T, Williams MC, Gray AJ, Mills NL, Lee KK. Risk scores and coronary artery disease in patients with suspected acute coronary syndrome and intermediate cardiac troponin concentrations. Open Heart. 2024 Aug 3;11(2):e002755. doi: 10.1136/openhrt-2024-002755.

  PMID: 39097328 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The study aims to take four blood samples from study participants at time of consent if this is done in person and also at time of CTCA in the intervention arm for long-term storage. The sample types and volumes are detailed below: * Plasma Li-Hep (approx. 4.7ml) * Serum Gel (approx. 9ml) * EDTA (approx. 4.9ml) * EDTA (approx. 9ml) Where possible, surplus serum and/or plasma will also be obtained from the clinical blood samples sent by the clinical care team during the initial hospital attendance. All samples will be centrifuged and stored at -80 degrees Celsius.

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 16, 2020
• Study Start: December 4, 2018
• Primary Completion: October 6, 2020
• Study Completion: October 6, 2020
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

GB (1)