Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction: The Step-in-AMI Trial (Short TErm Psychotherapy IN Acute Myocardial Infarction)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- The cumulative incidence of new cardiological events and the occurrence of new medical pathologies
研究概览
简要总结
Psychosocial factors play an important role in the pathophysiology of acute myocardial infarction (AMI), but it is not known if psychotherapy is beneficial after the contemporary treatment of AMI consisting of medical and interventional therapy.
The investigators have designed a randomized, controlled study to assess the effects of short-term psychotherapy (STP) on the clinical outcomes of patients who have undergone an emergency percutaneous coronary intervention (PCI) post-AMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to San Filippo Neri Hospital for AMI and treated with primary or urgent PCI.
- •Primary PTCA is performed up to 12 hours after the beginning of chest pain in cases of STEMI, while patients with NSTEMI are enrolled if urgent PTCA is being performed within 48 hours of the onset of chest pain.
- •Only patients in whom complete revascularization is achieved are being enrolled in the study.
排除标准
- •Patients with psychiatric disorders or disability, cognitive impairment, or other life-threatening conditions are being excluded from the study.
研究组 & 干预措施
Psychotherapy
Psychotherapy and medical therapy
干预措施: Psychotherapy (Behavioral)
Control
Optimal medical therapy
干预措施: Medical therapy (Drug)
结局指标
主要结局
The cumulative incidence of new cardiological events and the occurrence of new medical pathologies
时间窗: 5 years
次要结局
- Incidence of re-hospitalisations(5 years)
研究者
Christian Pristipino
MD, Head of Research and Training section, Interventional Cardiology Unit
San Filippo Neri General Hospital