Fact CheckerSign in

NCT06743672Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
6500 (estimated)
First submitted
16 Dec 2024
Start date
15 Jun 2025
Primary completion date
31 Dec 2026
Lead sponsor
University of Calgary
NCT number
NCT06743672

What you commit to

  • Study type: Observational
  • Planned participants: 6500
  • From 15 Jun 2025 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Acute coronary syndrome or revascularization in previous 30 days;

Other illness

  • 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.

Other

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

Who the study is looking for

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

Age in the registry: 25 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Of Calgary
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.