A Real-world Registry Study of Multidisciplinary Collaborative Diagnosis and Treatment Model for Cardioembolic Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Composite end point of cardiovascular and cerebrovascular events
研究概览
简要总结
Study Title: A real-world registry of multidisciplinary collaborative diagnosis and treatment models for cardioembolic stroke
Research Objectives:
① Main objective: To establish a multidisciplinary assisted diagnosis and treatment model for patients at high risk of cardioembolic stroke, manage and collect the diagnosis, treatment and prognosis data of patients.
② Secondary objective: To investigate the improvement of cardioembolic stroke, cardiovascular complex events, recurrent stroke and all-cause mortality risk, quality of life, and cardiac function between the "multidisciplinary assisted treatment model" group and the "conventional treatment model group". The routine diagnosis and treatment mode can match the patients who did not adopt the "multidisciplinary assisted diagnosis and treatment mode" in the same period.
Type of design: A prospective, observational, real-world study. No fixed diagnosis and treatment plan was established in advance, and only a multidisciplinary assisted diagnosis and treatment model was established. All treatment choices were made by clinicians according to the expert consensus of relevant textbooks and clinical guidelines, and according to the patient's condition.
Subjects: From September 2022 to September 2023, high-risk patients with cardioembolic stroke were collected from the Second Affiliated Hospital of Nanchang University and sub-centers of hospitals at all levels in Jiangxi Province.
详细描述
Summary of Research Protocol:
Study Title: A real-world registry of multidisciplinary collaborative diagnosis and treatment models for cardioembolic stroke
Research Objectives:
① Main objective: To establish a multidisciplinary assisted diagnosis and treatment model for patients at high risk of cardioembolic stroke, manage and collect the diagnosis, treatment and prognosis data of patients.
② Secondary objective: To investigate the improvement of cardioembolic stroke, cardiovascular complex events, recurrent stroke and all-cause mortality risk, quality of life, and cardiac function between the "multidisciplinary assisted treatment model" group and the "conventional treatment model group". The routine diagnosis and treatment mode can match the patients who did not adopt the "multidisciplinary assisted diagnosis and treatment mode" in the same period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The risk of high embolism (including intracardiac thrombosis, intracardiac tumor, aortic atherosclerosis, atrial fibrillation and spontaneous ultrasound imaging) was in line with the risk stratification criteria of Chinese Expert Consensus on the Diagnosis of cardiogenic Stroke (2020);
- •In accordance with the Chinese Expert Consensus on the Treatment of cardiogenic Stroke (2022), surgical indications for cardiac diseases (including left atrial appendage closure, left atrial appendage ligation, and radiofrequency ablation of atrial fibrillation are recommended for high-risk stroke patients with atrial fibrillation; For cryptogenic stroke patients with high-risk PFO, transcatheter PFO closure is recommended. Valve repair or replacement);
- •Understand and voluntarily sign the informed consent.
排除标准
- •Serious mental disorder, unable to express the will;
- •In the judgment of the investigator, there are obvious other abnormal signs, laboratory tests and clinical diseases, which are not suitable for investigator participation;
- •Researchers judged that long-term follow-up could not be completed
结局指标
主要结局
Composite end point of cardiovascular and cerebrovascular events
时间窗: 1.5 years
Non-fatal ischemic stroke, non-fatal hemorrhagic stroke, non-fatal myocardial infarction, non-fatal heart failure, cardiovascular and cerebrovascular death
次要结局
- Cardiovascular and cerebrovascular death, All-cause death, Cardiac insufficiency, Cognitive dysfunction(1.5 years)
研究者
Xiao Huang
Principal Investigator
Second Affiliated Hospital of Nanchang University