Predictive Modelling of Clinically Significant Depressive Symptoms After Coronary Artery Bypass Graft Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire (PHQ-9) score ≥10 (yes/no) at 6 weeks post-CABG
研究概览
简要总结
The primary goal of this project is to develop a predictive model for clinically significant depressive symptoms (CSDS) in patients undergoing coronary artery bypass graft (CABG) surgery, using pre- and perioperative data. CSDS occur in about 30 percent of CABG patients, which is four times higher than in the general population. These symptoms are linked to poor quality of life and increased morbidity and mortality. The aim is to create a model that can identify patients at risk for postoperative depression. This tool could help clinicians make informed decisions and take preventive measures to manage depression after surgery.
详细描述
In patients undergoing coronary artery bypass graft (CABG) surgery, the prevalence of clinically significant depressive symptoms (CSDS) is about 30 percent, four times higher than the 12-month prevalence in the general population. CSDS are associated with poor quality of life and increased morbidity and mortality. While several predictors of post-CABG CSDS have been identified, no prognostic model exists.
The aim of this project is to develop a predictive model for post-surgery CSDS in CABG patients using pre- and perioperative data. A prognostic prediction model for CSDS 6 weeks post-CABG, will be developed using demographic, psychometric, medical, inflammation, and cardiac interoception data. Machine learning algorithms will be employed for data analysis. A cohort of 350 participants from two hospitals will be recruited, with 300 participants expected to complete the study. Data will be divided into training (200 participants) and testing (100 participants) sets. Nested cross-validation will prevent overfitting. Both binary and regression prediction models will be used. Additionally, a simpler model will be developed to increase generalizability.
The prediction model will identify CABG patients at risk of post-surgery CSDS. The model will help identify patients at risk for CSDS before surgery, enabling early interventions. Clinicians can make precision medicine decisions to prevent or manage CSDS, improving postoperative psychological well-being. Additionally, the study could advance understanding of the mechanisms linking depression and coronary heart disease, particularly in relation to inflammation and interoception.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective Off-Pump CABG or CABG, either isolated or combined with valve intervention
- •Men and women, aged between 18 and 90 years
- •Sufficient knowledge of German language in reading and understanding
- •Oral and Signed consent form
- •Ability and Willingness to follow the study protocol
排除标准
- •Cognitive impairment according to a score of ≤ 7 (maximum score = 9) on a modified version of a short version of the Mini-Mental State Examination and the Brief Interview for Mental Status
- •Any serious comorbid non-cardiac medical condition likely to cause death within 1 year (e.g. metastatic cancer)
- •Active psychotic symptoms (assessed with two items from the Youth Psychosis At Risk Questionnaire), substance abuse and/or dependence within the past 6 months (assessed with a single-item questionnaire), and/or active suicidal ideations (assessed with a single item from the M.I.N.I.).
- •Acute or emergency CABG
结局指标
主要结局
Patient Health Questionnaire (PHQ-9) score ≥10 (yes/no) at 6 weeks post-CABG
时间窗: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)
The Patient Health Questionnaire (PHQ)-9 will assess the severity of self-rated depressive symptoms over the last two weeks. It covers the nine Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) criteria for major depression, with symptoms rated on a 4-point Likert scale. Scores range from 0 to 27, with higher scores indicating more severe symptoms. A score of 10 or higher corresponds to a diagnosis of depression, with 88 percent sensitivity and specificity. As the best cut-off for post-CABG CSDS is difficult to determine a priori for a prediction model, a two complementary approaches for the analysis will be used, correcting for multiple tests when assessing the significance of the accuracy of the prediction model. One approach frames the prediction challenge as a binary classification problem and uses a PHQ-9 cut-off score ≥10 for defining the presence versus absence of CSDS.
次要结局
- PHQ-9 score continuous at 6 weeks post-CABG(Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery))
- General Anxiety Disorder (GAD-7) score ≥10 (yes/no) at 6 weeks post-CABG(Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery))
- GAD-7 score continuous at 6 weeks post-CABG(Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery))
- PTSD (Post-traumatic Stress Disorder) Checklist for DSM-5 (PCL-5) score ≥33 at 6 weeks post-CABG(Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery))
- PCL-5 score continuous at 6 weeks post-CABG(Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery))
- Short-Form Health Survey-12 (SF-12) mental health component score at 6 weeks post-CABG(Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery))
- SF-12 physical health component score at 6 weeks post-CABG(Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery))
研究者
Roland von Känel
Prof. Dr. med.
University of Zurich