Troponin to Risk Stratify Patients for Computed Tomography Coronary Angiography (PRECISE-CTCA)

Troponin Within the Normal Reference Range to Risk Stratify Patients With Acute Chest Pain 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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome
• Intervention / Treatment: Diagnostic test: Computed Tomography Coronary Angiography

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH16 4SB
    • Centre for Cardiovascular Science, University of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with moderate non-obstructive coronary artery disease	Proportion of participants with 50-70% stenosis in one or more coronary arteries	Ideally within 4 weeks of index presentation
Proportion of participants with mild non-obstructive coronary artery disease	Proportion of participants with 10-50% stenosis in one or more coronary arteries	Ideally within 4 weeks of index presentation
Proportion of participants with insignificant coronary artery disease	Proportion of participants with 1-10% stenosis in one or more coronary arteries	Ideally within 4 weeks of index presentation
Proportion of participants with normal coronary arteries	Proportion of participants with no stenosis in coronary arteries	Ideally within 4 weeks of index presentation

Other Outcome Measures

Outcome Measure	Time Frame
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
Proportion of participants with hemodynamically significant coronary stenosis on CT-derived fractional flow reserve (CT-FFR)	Ideally within 4 weeks of index presentation
Left ventricular volume	Ideally within 4 weeks of index presentation

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian; British Heart Foundation

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Actual): October 6, 2020
• Study Completion (Actual): October 6, 2020

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Coronary artery disease; CT coronary angiography; High-sensitivity cardiac troponin
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome
• Other Study ID Numbers: 245971

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Requests for IPD will be considered on an individual basis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No