Predictors and Clinical Outcomes of Patients With Coronary Heart Disease Co-morbid Depression Post Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,600
- 试验地点
- 1
- 主要终点
- Number of Participants with Major Adverse Events
研究概览
简要总结
A prospective, multicenter, registered cohort study to observe the incidence of 1-year major adverse cardiac events in patients with coronary heart disease co-morbid depression treated with percutaneous coronary intervention and to clarify the predictors of 1-year major adverse cardiac events post PCI among these patients.
详细描述
Coronary heart disease (CHD) is a clinical relevant psychosomatic issue. Treatment strategies include percutaneous coronary intervention (PCI), guidelines medication (GDMT) and coronary artery bypass grafting (CABG) were clinical proven to be effective to realize myocardial revascularization post CHD. Previous studies revealed that diagnosed depressed CHD patients have 3.6 times higher risk of major adverse events (MACE) post percutaneous coronary intervention than nondepressed. However, a reliable explanation of how depression impact clinical outcomes of CHD patients post PCI is lacking. The objective of this study is to observe the incidence of major adverse cardiovascular events in patients with coronary heart disease co-morbid with depression post PCI, and to explore a prognostic model of clinical outcomes based on physiological, interventional, socio-economic and psychological factors among these patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures;
- •Men and women 18 years or older；
- •Diagnosed CHD needed to and can be treated with PCI according to the guidelines of ACC/AHA；
- •Willingness to participate in the follow-up study for at least 1 year.
排除标准
- •Inability to provide written informed consent;
- •Diagnosed mental illness or medical history (including schizophrenia, bipolar disorder, severe dementia or Lifetime alcohol or substance abuse);
- •Tendency of suicide;
- •Pregnant or lactating women;
- •Any physical or intellectual inability or disability that may affect completion of self-assessment tools, study protocol and follow-up requirements;
- •Any other reasons that investigators based on professional judgments that would place the patient at increased risk.
- •Patient with STEMI within 24-hour from the onset of chest pain to admission.
结局指标
主要结局
Number of Participants with Major Adverse Events
时间窗: 36-month
major adverse events were including all-cause mortality, myocardial infarction, in-stent thrombosis and target vessel revascularization.
次要结局
- Number of Participants with All-cause Mortality(36-month)
- Number of Participants with Cardiovascular Mortality(36-month)
- Number of Participants with Myocardial Infarction(36-month)
- Number of Participants with In-Stent Thrombosis(36-month)
- Number of Participants with Target-Lesion Revascularization(36-month)
研究者
Shaoliang Chen, MD
Vice President
Nanjing First Hospital, Nanjing Medical University