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临床试验/NCT02807532
NCT02807532已完成不适用

Relationship Between Apelin and New-onset Atrial Fibrillation After Coronary Artery Bypass Grafting: a Prospective Cohort Study and Retrospective Case-Control Clinical Trial

General Hospital of Shenyang Military Region0 个研究点目标入组 120 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
主要终点
Incidence of new-onset atrial fibrillation

研究概览

简要总结

To investigate whether apelin can be used as an indicator to predict postoperative atrial fibrillation in patients with coronary atherosclerotic heart disease, and to provide an objective basis for the clinical selection of a preventive intervention program for atrial fibrillation.

详细描述

Atherosclerosis is a systematic and progressive pathological process, which commonly occurs in the intima of large and medium-sized arteries. The disease can lead to degenerative, proliferative, non-inflammatory lesions; thickening, hardening, and loss of elasticity of the vascular wall, and vascular stenosis; and reduced arterial blood flow. Eventually, organ damage occurs. Coronary atherosclerotic heart disease is the most common chronic degenerative disease caused by atherosclerosis.

Coronary artery bypass grafting (CABG) can effectively increase myocardial blood supply, prevent myocardial infarction, and improve quality of life, and is associated with low rates of surgical complications and mortality. However, new-onset atrial fibrillation is a common complication after coronary artery bypass grafting, with an incidence rate of 30%. It induces hemodynamic instability, is often accompanied by left-ventricular systolic dysfunction and congestive heart failure, and increases the risk of stroke.

Several studies have shown that the initiation and maintenance of atrial fibrillation is strongly associated with inflammation, which affects the electrical and structural remodeling of the heart. The role of C-reactive protein (CRP), a marker of inflammation, has been widely investigated. C-reactive protein is a non-specific acute-phase protein, and is elevated in many cardiovascular diseases, including coronary atherosclerotic heart disease, heart failure and hypertension. Elevated C-reactive protein levels are not only associated with simple and post-surgical atrial fibrillation, but also with cardioversion and recurrence of atrial fibrillation after ablation. However, there is no elevation of C-reactive protein levels in lone atrial fibrillation, indicating that inflammation is associated with cardiovascular disease, but not with atrial fibrillation per se. One of the aims of the present study is to determine how C-reactive protein levels in patients with new-onset atrial fibrillation change after coronary artery bypass grafting.

Apelin has anti-inflammatory effects in different tissues. Ellinor et al. showed that levels of apelin-12 were remarkably low in patients with atrial fibrillation. Recurrence of atrial fibrillation is high in patients with persistent atrial fibrillation and low apelin-12 levels after electrical cardioversion.

Apelin is an endogenous ligand of the G-protein coupled receptor APJ, and exhibits homology to angiotensin II. The signaling system stimulated by apelin regulates many physiological functions and pathological processes. The main target of apelin is the cardiovascular system; it dilates blood vessels, and has antifibrotic and positive inotropic effects. Falcone et al. showed that the risk of recurrence of atrial fibrillation was 3.1 times greater in patients with low apelin levels than those with high apelin levels. Furthermore, Yang et al. concluded that apelin levels were lower in patients with different types of atrial fibrillation than in controls, indicating that apelin might contribute to the initiation and maintenance of atrial fibrillation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meet WHO diagnostic criteria for coronary atherosclerotic heart disease
  • Are scheduled to undergo coronary artery bypass grafting
  • Have no history of atrial fibrillation
  • Have no history of thoracotomy
  • Provide written informed consent, having understood the benefits and risks of participation in the trial

排除标准

  • Valvular heart disease requiring surgical treatment
  • Severe cerebrovascular disease
  • Malignant tumor
  • Severe autoimmune disease
  • Thyroid dysfunction
  • Severe infection
  • Heart failure or acute myocardial infarction in the past month
  • Severe dysfunction of the heart, liver or lung
  • Refusal to cooperate with specimen collection and laboratory examination
  • Ongoing participation in other clinical trials
  • Unable to provide informed consent owing to mental disorders or language barriers

结局指标

主要结局

Incidence of new-onset atrial fibrillation

时间窗: 7 days after surgery

次要结局

  • Plasma apelin levels(7 days after surgery)
  • Plasma brain natriuretic peptide level(7 days after surgery)
  • Plasma high-sensitivity C-reactive protein level(7 days after surgery)
  • Cardiac MRI evaluation(7 days after surgery)

研究者

发起方
General Hospital of Shenyang Military Region
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shu Xu

Attending Physician

General Hospital of Shenyang Military Region

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