Clinical Outcomes of Cardiovascular Disease: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Heart failure
研究概览
简要总结
This study is a prospective, single center cohort study that primarily registers the clinical characteristics, outcomes, and influencing factors of patients with different types of cardiovascular diseases. Evaluate multiple examination indicators of patients at baseline, 1 year and longer, and follow up on the incidence of major cardiovascular and cerebrovascular adverse events, heart failure readmission, death, and other endpoint events.
详细描述
This study is a prospective, single center cohort study that primarily registers the clinical characteristics, outcomes, and influencing factors of patients with different types of cardiovascular diseases. Mainly including coronary heart disease, cardiomyopathy, hypertension, heart failure and other diseases, multiple examination indicators are evaluated for patients at baseline, 1 year and longer periods of time. The primary endpoints for coronary heart disease are all-cause mortality, cardiogenic death, non fatal myocardial infarction, hospitalization for heart failure, and major cardiovascular adverse events. The primary endpoints for cardiomyopathy are all-cause mortality, cardiogenic death, hospitalization for heart failure, and major cardiovascular adverse events. The primary endpoints for hypertension are stroke, all-cause mortality, cardiogenic death, hospitalization for heart failure, and major cardiovascular and cerebrovascular adverse events. The primary endpoints for heart failure are all-cause mortality, cardiogenic death, readmission for heart failure, and major cardiovascular adverse events.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary heart disease According to coronary angiography and coronary CTA, at least one coronary artery has a degree of stenosis greater than 50%.
- •Hypertension Hypertension is defined as office systolic blood pressure is ≥ 140mmHg and/or the diastolic blood pressure is ≥ 90mmHg without the use of antihypertensive drugs.
- •Heart failure There is a clear history of organic heart disease, clinical symptoms and signs of heart failure, and objective evidence of heart failure.
- •Cardiomyopathy Including defined dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, etc.
- •Able to sign informed consent form.
排除标准
- •Age<18 years old, or>80 years old.
- •Patients with various malignant tumors.
- •Liver dysfunction (defined as ALT or total bilirubin greater than three times the upper normal limit).
- •Renal insufficiency (defined as blood creatinine exceeding 1.5 times the upper normal limit).
- •Those who have participated in other clinical studies within the past three months.
- •Individuals without legal capacity or with limited legal capacity.
- •Any situation where the researcher deems it unsuitable to participate in the clinical study.
结局指标
主要结局
Heart failure
时间窗: 1 year.
Heart failure (HF) is defined according to the diagnostic criteria for HF. Briefly, HF was defined as typical signs and symptoms of HF (NYHA class III or IV), as well as a history of myocardial infarct (MI) or with advanced coronary artery disease including severe 3-vessel disease and chronic total occlusion or other Organic heart disease.
Stroke
时间窗: 1 year.
Stroke was defined as a sudden onset of vertigo, numbness, aphasia, or dysarthria caused by cerebrovascular disease, including hemorrhage, embolism, thrombosis, or aneurysm rupture, and persisting for \> 24 hours
Cardiac death
时间窗: 1 year.
Death caused by cardiac reasons.
Main adverse cardiovascular events（MACE）
时间窗: 1 year.
The composite endpoint for hospitalization for heart failure, non fatal myocardial infarction, and cardiac death.
All cause death
时间窗: 1 year.
Death caused by various reasons.
次要结局
- Main adverse cardiovascular and cerebrovascular events（MACCE）(3 years.)
- Cardiac death(3 years.)
- Main adverse cardiovascular events（MACE）(3 years.)
- All cause death(3 years.)
- Heart failure(3 years.)
- Stroke(3 years.)
研究者
Xiang Xie
Director
Xinjiang Medical University