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临床试验/NCT07388108
NCT07388108招募中不适用

Atrial Electromechanical Alteration as a Predictor of Arrhythmias in the Postoperative Period After Cardiovascular Surgery

School of Medicine. National University of Cuyo1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2026年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
138
试验地点
1
主要终点
Incidence of postoperatory atrial fibrillation

研究概览

简要总结

This study aims to improve the prediction for developing arrhythmias in the postoperative period of cardiovascular surgery by using non-invasive echocardiographic techniques that are sensitive to detect inter and intra-atrial dyssynchrony. The main question it aims to answer is:

Do patients with atrial dyssynchrony are at increased risk of developing arrhythmias in the postoperative period of cardiovascular surgery?

Patients admitted to the protocol will undergo an echocardiogram with atrial strain before surgery to determine the presence or absence of intra- and inter-atrial dyssynchrony and will be followed during hospitalization to assess the occurrence of atrial fibrillation in the postoperative period.

详细描述

The overall objective is to improve the prediction of the risk of developing arrhythmias in the postoperative period with non-invasive techniques that are sensitive to detect inter- and intra-atrial dysrhythmias.

Specific objectives

  1. To describe the alterations in left and right atrial deformation by strain method to identify intra- and inter-atrial activation dyssynchrony.
  2. To determine that dyssynchrony predicts a higher incidence of atrial fibrillation in the postoperative period after cardiovascular surgery.
  3. To evaluate whether novel atrial function analysis techniques, such as left atrial ejection fraction assessed via 3D echocardiography, are associated with a higher incidence of postoperative atrial fibrillation.

All patients will undergo a full Doppler echocardiogram with two-dimensional atrial Strain determination with speckle tracking, using an Philips EPIC CVx series echocardiogram machine with S5-1 and X5-1 probes. The images will be obtained in left lateral decubitus. In forced expiration, 3 consecutive beats will be recorded and digitally saved for later analysis in the 4 and 2 chamber views. Both atria must be visualized so that neither atrial wall are lost in the evaluation. Echocardiographic measurements will focus primarily on the indexed left atrial volume obtained by averaging the values obtained in 2 and 4 chambers by the multiple disc method. In these views, the left ventricular ejection fraction will be obtained by the Simpson biplane method. The left atrium will be further subdivided into basal, medial and atrial roof segments, resulting in a total of 12 segments, 6 of which can be observed in the four-chamber view and 6 in the two-chamber view. The right atrium will be divided similarly but will contribute a mere three additional segments to the total (for a total of 15 segments), as the right septal segments were previously regarded as part of the left atrium. The time to maximum deflection, defined as the interval between the onset of the P wave on the electrocardiogram and the maximum deflection of the atrial contraction determined by strain rate, will be measured for each of the 15 atrial segments previously described. To determine interatrial synchrony, an adaptation of the atrial strain will be made so that both atria can be evaluated simultaneously. This new evaluation, which we have designated "OMEGA" (ω) due to its resemblance to the shape of the strain image, will yield the time to maximum deformation of the lateral segments of the right atrium and the lateral segments of the left atrium. Consequently, the difference in activation timing between the lateral segments of the right and left atria will determine the presence of an activation delta between the walls.

A comprehensive analysis of atrial deformation using left and right atrial strain will also be performed. Subsequently, the time-to-peak deformation will be measured from the onset of the P-wave to the peak negative atrial strain deflection, which correlates with atrial contractile strain. Activation time differences derived from this methodology will also be measured to provide an additional assessment of the interatrial activation delay (delta).

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with criteria for non-mitral cardiovascular surgery, in sinus rhythm, and who gave informed consent to participate in the study.
  • Absence of atrial fibrillation upon hospital admission for surgery.

排除标准

  • Surgery of the mitral or tricuspid valve.
  • History of previous atrial fibrillation.
  • History of congenital heart disease or cardiac tumors.
  • Emergency surgery of the heart
  • Pour echocardiographic window

结局指标

主要结局

Incidence of postoperatory atrial fibrillation

时间窗: From the end of surgery through hospital discharge, an average of 6 days.

Arrhythmic episodes of at least 30 seconds duration will be considered postoperative atrial fibrillation when detected on continuous monitoring or when detected on a ward ECG, if the patient reported symptoms or required medical intervention.

次要结局

  • Atrial Fibrillation at 28 and 365 Days(From surgery through Day 28 and Day 365)

研究者

发起方
School of Medicine. National University of Cuyo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francisco Javier Sánchez

MD; PhD

School of Medicine. National University of Cuyo

研究点 (1)

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