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

NCT06743672 | Not Yet Recruiting

• 1 other identifier: REB-24-0536
• Study Type: observational
• Target: 6,500
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.We will provide improved accounting for sex and the presence of pre-existing coronary disease compared to previous tools;
3. 3.We will incorporate the latest generation cardiac troponin assay;
4. 4.We will investigate the utility of other commonly available biomarkers that have excellent predictive utility in other cardiovascular diseases;
5. 5.We will undertake time-to-event analyses to suggest the optimal timing of additional cardiac testing;

Conditions

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Keywords

Coronary artery disease; chest pain; Emergency Medicine

Outcome Measures

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).

  30 days after initial ED encounter

Secondary Outcomes (1)

• MACE Components

  90 days of the index ED visits

Study Arms (1)

Emergency department patients with chest pain

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. Our age cutoff is consistent with prior literature, demonstrating a very low risk of symptomatic coronary disease below age 25. Inclusion Criteria 1. Symptoms of chest pain or of suspected cardiac ischemia; 2. Age 25 or older; 3. Hs-cTn concentration below diagnostic criteria for myocardial infarction, as specified in the Fourth Universal Definition of MI49; Exclusion Criteria 1. Acute ischemic ECG changes (ST segment elevation or depression, new T-wave inversion, New left bundle branch block; Wellen's/DeWinter T waves); 2. Alternative diagnosis identified in the ED (e.g. pneumonia, pulmonary embolism, aortic dissection, pancreatitis; peri/myocarditis); 3. Acute coronary syndrome or revascularization in previous 30 days; 4. Expected lifespan \< 6 months per treating

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Symptoms of chest pain or of suspected cardiac ischemia;
• Age 25 or older;

You may not qualify if:

• 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;
• Expected lifespan \< 6 months per treating clinician.

Sponsors & Collaborators

• University of Calgary: lead
• Network of Canadian Emergency Researchers (NCER): collaborator
• Canadian Emergency Department Research Network: collaborator
• Canadian Instistutes of Health Research: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N2T9, Canada

Location

Related Publications (1)

• McRae AD, Macci AJ, Holodinsky JK, Sajobi TT, Andruchow JE, Borgundvaag B, Brooks S, Cheng I, Deb S, Fok P, Kavsak PA, Graham MM, Lee J, McLeod SL, Scheuermeyer F, Thiruganasambandamoorthy V, Wiemer H, Yan JW, Hohl CM. Development of a Novel Risk-Prediction Tool for Emergency Department Patients with Symptoms of Coronary Artery Disease: A Research Study Protocol. CJC Open. 2025 Mar 26;7(6):777-783. doi: 10.1016/j.cjco.2025.03.016. eCollection 2025 Jun.

  PMID: 40586028 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction; Chest Pain

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Central Study Contacts

Andrew McRae, MD, PhD

CONTACT

403-210-8835; amcrae@ucalgary.ca

Aysha Macci

CONTACT

ajmacci@ucalgary.ca

Study Design

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

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: June 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-03

Locations

CA (1)