Development of a Novel Risk Prediction Tool for Emergency Department Patients Symptoms of Coronary Artery Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25+
SponsorUniversity of Calgary

About this trial

Patients with chest pain and symptoms of acute coronary syndromes (ACS) account for over 600,000 emergency department (ED) visits annually in Canada. 85% of these patients do not have an ACS, and most are discharged from the ED after a thorough evaluation. However, a large proportion of these patients (approximately 180,000 annually) are referred for outpatient objective cardiac testing (exercise stress tests, myocardial perfusion scans, coronary CT angiography) after ED discharge, even though their short-term risk of major adverse cardiac events such as death, new myocardial infarction or need for revascularization is very small. This contributes to substantial low-value healthcare utilization, and limits access for those patients who are likely to benefit from objective testing.

Clinical risk prediction tools can improve the appropriateness of utilization of cardiac testing. However, existing risk prediction tools were developed prior to the advent of new high-sensitivity cardiac troponin assays, were derived in non-representative populations and, when applied to ED patients with low cardiac troponin concentrations, systematically overestimate short-term risk of major adverse cardiac events (MACE).

New, more specific, risk prediction tools are required to accurately guide clinical decision-making for patients who have had an emergency department evaluation for suspected coronary disease. The objective of this research program is to develop individualized risk prediction tools for patients who have had an MI ruled out in the emergency department, to identify patients who are likely to benefit from additional cardiac testing, and to guide the appropriate timing of testing. In other words, the objective is to provide personalized risk estimates to get the Right Patient the Right Test at the Right Time.

We will conduct a multicenter prospective cohort study including emergency department chest pain patients to derive personalized risk prediction tools to distinguish patients at low risk of MACE and not requiring additional cardiac testing from patients who are likely to benefit from additional cardiac testing. We will leverage the existing clinical research infrastructure of the Canadian Emergency Department Rapid Response Network to enrol a large population of representative patients.

The risk prediction tools that we will develop will innovate in the following ways:

1. We will include the right population, namely patients who have had MI ruled out in the ED, as current risk prediction tools were derived in different populations; 2. We will provide improved accounting for sex and the presence of pre-existing coronary disease compared to previous tools; 3. We will incorporate the latest generation cardiac troponin assay; 4. We will investigate the utility of other commonly available biomarkers that have excellent predictive utility in other cardiovascular diseases; 5. We will undertake time-to-event analyses to suggest the optimal timing of additional cardiac testing;

5\) We will provide granular, individualized risk estimates to guide decision-making around which patients need additional testing.

The knowledge product of this work will improve patient outcomes while also optimizing the appropriate utilization of objective cardiac testing modalities.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Symptoms of chest pain or of suspected cardiac ischemia;

Age 25 or older;

Disqualifiers

Diagnosis of Myocardial Infarction in the Emergency Department; OR Maximal high-sensitivity cardiac troponin concentration 115 ng/L or Higher; OR Change between serial samples of high-sensitivity troponin >3ng/L AND >30% of initial concentration.

Acute ischemic ECG changes (ST segment elevation or depression, new T-wave inversion, New left bundle branch block; Wellen's/DeWinter T waves);

Alternative diagnosis identified in the ED (e.g. pneumonia, pulmonary embolism, aortic dissection, pancreatitis; peri/myocarditis);

Acute coronary syndrome or revascularization in previous 30 days;

Trial population

We will enroll adult patients (age \>25) presenting to the ED with chest pain or symptoms consistent with coronary disease, but who do not have an MI or clear alternative diagnosis.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

6,500 Participants
are grouped into 1 trial group
Group A: Emergency department patients with chest pain

Trial outcomes

Primary outcomes

1

Major Adverse Cardiac Events

The primary outcome for the prediction tool will be the incidence of MACE within 30 days after the index ED visit. MACE is defined as all-cause mortality, MI, or revascularization (non-elective coronary bypass grafting or percutaneous coronary intervention).

Time frame
30 days after initial ED encounter

Secondary outcomes

1

MACE Components

Secondary outcomes include individual MACE components: all-cause mortality, MI, and revascularization within 90 days of the index ED visit.

Time frame
90 days of the index ED visits

Other outcomes

Sponsors and contacts

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University of Calgary

Lead sponsor

Network of Canadian Emergency Researchers (NCER)

Collaborator

Canadian Emergency Department Research Network

Collaborator

Canadian Instistutes of Health Research

Collaborator

This trial is not recruiting at the moment. You can still explore other options: