Correlation of Clinical Outcomes With ECG Findings in Patients With Left Bundle Branch Block Being Evaluated for Acute Coronary Syndrome - a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 主要终点
- Negative likelihood ratio of non-discordant T waves for prediction of positive cardiac biomarkers on index visit
研究概览
简要总结
Purpose of the study:
The goal of this study is to evaluate the relationship of electrocardiogram (ECG) findings with clinical outcomes in a cohort of patients with left bundle branch block (LBBB) who are being evaluated for acute coronary syndrome (ACS) in the Emergency Department (ED).
Background and significance:
The significance of specific ECG findings in patients with LBBB being evaluated for ACS has been inadequately studied, and this gap in knowledge is a barrier to optimal management of this population. Due to the speed, availability, low cost, and non-invasive nature of the ECG, it would be ideal to identify ECG characteristics that help to risk stratify these patients in order to inform clinical decision-making, reduce unnecessary invasive testing, and conserve resources.
Methods:
In this prospective observational study the investigators will identify a consecutive series of adult patients with LBBB presenting to the ED with suspicion of ACS. The investigators will collect data including demographics, cardiac risk factors, initial ECG measurements, lab and radiographic results, procedure results, and clinical outcomes such as 30-day death or myocardial infarction (MI). The investigators will analyze the data using a cohort study design to calculate odds ratios between ECG characteristics and the outcomes of interest.
详细描述
Purpose of the study:
The goal of this study is to identify initial electrocardiogram (ECG) findings (including ST/S ratio and T-wave morphology) that predict clinical outcomes (myocardial infarction, positive stress test, revascularization and death), in a cohort of Emergency Department (ED) patients with left bundle branch block (LBBB) who are being evaluated for acute coronary syndrome (ACS).
Design & procedures:
The investigators will prospectively identify all adult (18yrs and older) patients presenting to their institution's ED who are being evaluated for ACS and have LBBB on ECG. The investigators will collect data on demographics (including age, but not date of birth), cardiac risk factors, date and time of presentation to the ED, ECG measurements, lab and radiographic results (cardiac biomarker data including date and time of the sample, stress test results, coronary imaging results, coronary catheterization results) and clinical outcomes such as 30-day death or MI. They will collect copies of ECGs and measure the following: ST/S ratio (ratio of the amplitude of ST segment deviation to the S wave amplitude); T-wave morphology (entirely discordant, entirely concordant, or biphasic to the PR interval); and standard ST segment deviation. A logistic regression analysis will be used to identify which ECG features are associated with 30-day death, MI, and revascularization. In the sub-cohort of subjects with negative "modified Sgarbossa criteria" a subanalysis will identify the outcome rates for the following specific sub-populations: those less than 2 consecutive partially-concordant T-wave leads and those with 2 or more consecutive partially-concordant T-wave leads.
Selection of Subjects:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older
- •LBBB on ECG
- •Presenting to the ED and being evaluated for ACS
排除标准
- •Prisoners
- •Institutionalized individuals
- •Patients who are incapable of giving legally effective consent
- •Patients who cannot understand spoken English
结局指标
主要结局
Negative likelihood ratio of non-discordant T waves for prediction of positive cardiac biomarkers on index visit
时间窗: The ECG will be the ECG on presentation to the ED. The maximum cardiac troponin within 48 hours of index visit will be used as the outcome.
Diagnostic properties (sensitivity, specificity, likelihood ratios) of item 1 for item 2 below: 1. Presence of at least two ECG leads with non-discordant T waves (meaning either entirely concordant or biphasic, relative to the PR interval) 2. Positive (above the assay's normal reference range) cardiac biomarkers (cardiac troponin I, T, or CK-MB) within 48 hours of presentation to the ED.
Sensitivity of non-discordant T waves for prediction of positive cardiac biomarkers on index visit
时间窗: The ECG will be the ECG on presentation to the ED. The maximum cardiac troponin within 48 hours of index visit will be used as the outcome.
Diagnostic properties (sensitivity, specificity, likelihood ratios) of item 1 for item 2 below: 1. Presence of at least two ECG leads with non-discordant T waves (meaning either entirely concordant or biphasic, relative to the PR interval) 2. Positive (above the assay's normal reference range) cardiac biomarkers (cardiac troponin I, T, or CK-MB) within 48 hours of presentation to the ED.
Specificity of non-discordant T waves for prediction of positive cardiac biomarkers on index visit
时间窗: The ECG will be the ECG on presentation to the ED. The maximum cardiac troponin within 48 hours of index visit will be used as the outcome.
Diagnostic properties (sensitivity, specificity, likelihood ratios) of item 1 for item 2 below: 1. Presence of at least two ECG leads with non-discordant T waves (meaning either entirely concordant or biphasic, relative to the PR interval) 2. Positive (above the assay's normal reference range) cardiac biomarkers (cardiac troponin I, T, or CK-MB) within 48 hours of presentation to the ED.
Positive likelihood ratio of non-discordant T waves for prediction of positive cardiac biomarkers on index visit
时间窗: The ECG will be the ECG on presentation to the ED. The maximum cardiac troponin within 48 hours of index visit will be used as the outcome.
Diagnostic properties (sensitivity, specificity, likelihood ratios) of item 1 for item 2 below: 1. Presence of at least two ECG leads with non-discordant T waves (meaning either entirely concordant or biphasic, relative to the PR interval) 2. Positive (above the assay's normal reference range) cardiac biomarkers (cardiac troponin I, T, or CK-MB) within 48 hours of presentation to the ED.
次要结局
- Specificity of various exploratory ECG findings for positive cardiac biomarkers(The ECG measurements at presentation to the ED will be used, to predict maximum cardiac troponin within 48 hours of presentation to the ED.)
- Positive likelihood ratio of various exploratory ECG findings for positive cardiac biomarkers(The ECG measurements at presentation to the ED will be used, to predict maximum cardiac troponin within 48 hours of presentation to the ED.)
- Negative likelihood ratio of various exploratory ECG findings for positive cardiac biomarkers(The ECG measurements at presentation to the ED will be used, to predict maximum cardiac troponin within 48 hours of presentation to the ED.)
- Sensitivity of various exploratory ECG findings for positive cardiac biomarkers(The ECG measurements at presentation to the ED will be used, to predict maximum cardiac troponin within 48 hours of presentation to the ED.)