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临床试验/NCT06743672
NCT06743672尚未招募不适用

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

University of Calgary1 个研究点 分布在 1 个国家目标入组 6,500 人开始时间: 2025年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
6,500
试验地点
1
主要终点
Major Adverse Cardiac Events

研究概览

简要总结

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;
  1. 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.

详细描述

Background

Chest pain and symptoms of coronary artery disease are a common cause for presentation to an emergency department <REF>. The key clinical question addressed in the ED is whether these patients have acute myocardial infarction (MI), which is associated with a 30-day mortality risk of 6.1%2. Therefore, patients presenting to the ED with chest pain and symptoms of possible MI typically undergo extensive investigations, including clinical evaluation and testing with electrocardiograms and blood cardiac troponin measurement. Among patients evaluated in the ED for chest pain, up to 10% are diagnosed with MI and admitted to the hospital. Another 5% are admitted for investigations because of concern for unstable angina, a syndrome of chest pain or other symptoms associated with critical coronary stenosis that does manifest a rise in troponin concentration3

The remaining 85% of patients, who have had MI and other high-risk diagnoses ruled out in the ED, have a short-term risk of Major Adverse Cardiac Events (MACE: Death, MI or revascularization) of 2.5% or less1,4,5. Recent guidelines reinforce that patients at low risk of MACE need not undergo additional testing to diagnose coronary disease at the time of their initial hospital encounter. However, in Canada, as many as 40% of these patients are referred for outpatient cardiac testing after ED discharge to screen for undiagnosed coronary disease4,6-8. In the United States, up to 70% of patients at low risk of MACE undergo additional testing, often as inpatients 12-14,35. This an ineffective use of healthcare resources. This low-value testing pattern is driven by reliance on outdated risk scores that overestimate risk of MACE, or use of "gut feeling" estimation of pre-test probability of coronary disease, based on the presence of traditional coronary disease risk factors.

Our objective is to derive, and internally validate, a novel risk prediction tool to accurately predict 30-day MACE among ED patients with chest pain in whom MI has been ruled out and are being considered for ED discharge. This risk prediction tool will guide rational, cost-effective decisions around which patients should be referred for additional cardiovascular testing after a thorough ED evaluation for chest pain. This new risk score will innovate compared to existing risk scores by integrating high-sensitivity troponin testing, specifically accounting for sex and sex-related risk factors, and the presence of pre-existing coronary artery disease.

Methods

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Major Adverse Cardiac Events

时间窗: 30 days after initial ED encounter

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).

次要结局

  • MACE Components(90 days of the index ED visits)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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