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临床试验/NCT00622024
NCT00622024已完成不适用

Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias

研究概览

简要总结

Postoperative arrhythmias (heart irregularities) are one of the most common complications after cardiac surgery and are associated with increased morbidity and mortality. Preoperative depression may be an important co-factor in the generation of postoperative arrhythmias due to sympathetic hyperactivity evident in patients with depression.

Objectives: To determine the effect of preoperative depression on postoperative arrhythmia in patients undergoing elective coronary artery bypass graft (CABG) surgery.

Prospective observational study, 120 patients undergoing elective CABG surgery ECG will be preformed preoperatively on all patients. All patients will be assessed for signs of depression using the Prime MD Patient Health Questionnaire (Prime MD PHQ) one week before surgery and 6 weeks postoperatively.Based on the Prime MD PHQ results, patients will be divided into two groups: those with or without signs of depression. Heart rate and rhythm monitoring with Holter will be performed for 3 days postoperatively in order to compare the incidence of postoperative arrhythmias between groups.

The primary outcome is the number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias. Secondary outcomes include all cause mortality, non-fatal myocardial infarction, cardiac arrest, and congestive heart failure.

CABG surgery is the most common operative procedure in North America and arrhythmias are one of the most common postoperative complication. It is estimated that about a third of these cardiac patients suffer from preoperative depression and therefore may be exposed to a higher risk of perioperative morbidity and mortality. If an association between preoperative depression and postoperative arrhythmia is found, treatment modalities may be indicated to reduce the prevalence of perioperative arrhythmia in patients with preoperative depression undergoing cardiac surgery.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18-75 years of age undergoing elective CABG surgery.
  • Patients must provide informed consent

排除标准

  • Patients with a history of arrhythmias (AF, supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, permanent pacemaker and/or defibrillator).
  • Patients who are unable to read.
  • Patients with significant psychiatric disorders other than depression.
  • Patients with a history of pulmonary hypertension.
  • Patients with a left ventricular ejection fraction < 40%.
  • Patients with cognitive impairment as measured by the MMSE.
  • Patients on antidepressants at the time of assessment

结局指标

主要结局

Number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias

时间窗: Depression assessment and holter monitor 3days postop

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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