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临床试验/NCT00321282
NCT00321282终止2 期

A Retrospective Analysis of the Predictive Potential of Pre-operative Data on Post-operative Atrial Fibrillation

Emory University6 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2006年2月最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
600
试验地点
6

研究概览

简要总结

Roughly thirty percent of people that undergo open heart surgery get an abnormal heart beat afterwards known as atrial fibrillation (AF). While not life threatening, this abnormal heart beat increases the likelihood of stroke and delays recovery. There are strategies to prevent post-operative AF, but they are costly and sometimes have undesirable side effects. Therefore, it would be best if we use these preventive treatments only in high risk patients.

We intend to develop a risk prediction model based on demographic and electrocardiogram (ECG) findings that will predicted who is likely to get AF. We will develop this model using data already available on patients who have undergone cardiac surgery. The development of this model will use the latest mathematical algorithms similar to those used to study genetic evolution. This type of model is capable of looking at many parameters in an unbiased way, so that only the strongest, independent predictors remain in the final model. Once, the model is developed, we will validate the model by comparing our predictions to actual outcomes previously recorded in the database.

详细描述

1.0 Background Currently, roughly thirty percent of coronary artery bypass graft (CABG) patients develop atrial fibrillation (AF) in the five days following surgery, increasing the risk of stroke, prolonging hospital stay three to four days, and increasing the overall cost of the procedure [1, 2]. According to some sources, over $1 billion is spent annually on this problem in the US alone [2]. Current pharmacologic and nonpharmacologic means of AF prevention are suboptimal, and their side effects, expense, and inconvenience limit their widespread use in all patients [3].

Though many methods have been presented touting high predictive value in terms of sensitivity and specificity for post-operative AF, none are reliable enough for use in a clinical setting. This may be due to the lack of a standardized method for the measurement of certain morphological P wave features in ECG analyses [4]. Furthermore, the medical community has relied on limited variable combination methods for much too long, especially while there are advanced methods of data mining and decision-making to be harnessed. A Bayesian network (BN) is an excellent tool for making decisions based on collected information and is even able to handle missing data points well [5]. By combining more types of data and expert knowledge into a BN with a Bayesian statistical approach, better accuracy is the likely result.

2.0 Objectives

The main objective of this research is to develop a Bayesian network (BN) classifier which can model/predict/assign risk of the occurrence of atrial fibrillation in coronary artery bypass graft patients through the incorporation of different types of patient data. Expert knowledge coming from doctors in the field will be combined using Bayesian statistics with patient data and electrocardiogram (ECG) analysis, improving on the Frequentist methods currently used. We intend to investigate profit or loss due to the inclusion of the following data types:

  • Collected Data- Risk factors and other medical indicators recorded in the hospital
  • ECG Features- Time, frequency, wavelet, and nonlinear domain features derived from the ECG signal showing AF prediction potential
  • Expert Knowledge- Cardiologist modified probability distribution and frequency beliefs of input data based on past experience This study will analyze data from patients who underwent cardiac surgery at Emory University Hospital, Crawford Long Hospital, or the Atlanta Veterans Affairs Medical Center. The collected data will include demographic, pre-operative, operative, and post-operative all taken from the patient's chart. ECG and available telemetry data will also be collected and analyzed for morphological features, which may yield AF predisposition clues.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To prevent post-operative atrial fibrillation

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samuel C. Dudley, Jr.

Principal Investigator

Emory University

研究点 (6)

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