the Risk Prediction Model of MACE After PCI in Patients With AMI Based on Multimodal Machine Learning and the Effect of Digital Therapeutics for Cardiac Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 655
- 试验地点
- 1
- 主要终点
- 6-minute walk test (6MWT)
研究概览
简要总结
A prospective, multicenter, observational study is adopted, with Jiangsu Provincial People's Hospital as the leading unit, and the other 13 Hospitals as cooperative units.
详细描述
The deployment of an integrated cardiac rehabilitation management platform from the hospital to the outside of the hospital is uniformly arranged, and based on this platform, a study on the construction of a MACE prediction model and disease risk stratification for patients with acute myocardial infarction after PCI is carried out. It is planned to include 655 inpatients after PCI for acute myocardial infarction. Among them, the leading unit completes the enrollment and follow-up of 44 patients, and each cooperative unit completes the enrollment and follow-up of 47 patients, and competitive enrollment is allowed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic criteria of AMI;
- •Ages 18 - 75 years old;
- •Meeting the indications for emergency PCI surgery, with informed consent and voluntarily undergoing PCI treatment; ④ Accurate and complete clinical relevant data; ⑤ First diagnosis and treatment; ⑥ All patients were given unified antiplatelet therapy after the operation; ⑦ All patients were followed up for 12 months after the operation.
排除标准
- •With malignant tumors, infections and other diseases;
- •Blood diseases, immune system diseases, severe liver and kidney function disorders; ③ With other heart diseases such as heart failure; ④ Patients undergoing surgical treatment.
结局指标
主要结局
6-minute walk test (6MWT)
时间窗: 12 months
The test requirements refer to the guidelines formulated by the American Thoracic Society. Instruct the patient to walk back and forth on a 30-meter-long corridor at the fastest speed. Once there are obvious symptoms such as chest tightness, dizziness, and breathing difficulties, the experiment should be stopped immediately, and the walking distance of the patient within 6 minutes should be detected and recorded after the experiment.
Cardiopulmonary exercise testing (CPET)
时间窗: 12 months
Cardiopulmonary exercise testing (CPET) refers to a method of examination that, under a gradually increasing exercise load, measures a series of indicator changes in the human body, including gas metabolism, heart rate, blood pressure, blood oxygen saturation, and electrocardiogram, from the resting state to the maximum exertion state during exercise and then back to the resting state. It records the corresponding symptoms that occur in the subjects during the testing process, objectively reflecting the physiological and pathological changes and the degree of functional impairment that occur at different load levels, thereby comprehensively evaluating the overall function and reserve capacity of organ systems such as the heart and lungs. The protocol used in this study is a symptom-limited incremental exercise test using a treadmill.
electrocardiogram
时间窗: At the time of enrollment
24-hour physiological data monitoring: Wear a wearable device, and the monitoring time is from 8:00 am to 8:00 am the next day. Collect physiological signals such as electrocardiogram to evaluate heart rate variability.
breathing and blood oxygen
时间窗: At the time of enrollment
24-hour physiological data monitoring: Wear a wearable device, and the monitoring time is from 8:00 am to 8:00 am the next day. Collect physiological signals such as blood oxygen to evaluate breathing patterns, sleep breathing events and sleep stagess.
Major Adverse Cardiovascular Events (MACE)
时间窗: 12 months
Major Adverse Cardiovascular Events (MACE): Major Adverse Cardiovascular Events include heart failure, cardiovascular death, arrhythmia, atrial fibrillation, ventricular tachycardia, all-cause mortality, readmission, cardiogenic shock, target vessel revascularization, new or worsening myocardial infarction, non-fatal stroke, etc.
次要结局
- Barthel Index(12 months)
- Left ventricular ejection fraction, LVEF(12 months)
- the assessment of the Generalized Anxiety Disorder 7-item scale (GAD-7)(12 months)
- the assessment of the Patient Health Questionnaire-9 (PHQ-9)(12 months)
研究者
Chen Leilei
Chief Physician
The First Affiliated Hospital with Nanjing Medical University