the Risk Prediction Model of Major Adverse Cardiovascular Events After PCI in Patients With Acute Myocardial Infarction 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
- 160
- 试验地点
- 1
- 主要终点
- electrocardiogram
研究概览
简要总结
This study adopts a multicenter, open-label, randomized controlled clinical study, with Jiangsu Provincial People's Hospital as the leading unit, and the other 13 hospitals as cooperative units.
详细描述
It uniformly deploys an integrated cardiac rehabilitation management platform from the hospital to outside the hospital. Based on this platform, precise cardiac rehabilitation for myocardial infarction patients based on continuous dynamic physiological data is carried out. A total of 160 myocardial infarction patients after PCI who will undergo digital therapy cardiac rehabilitation are randomly divided into a digital cardiac rehabilitation group (experimental group) and a conventional treatment group (control group) at a ratio of 1:1 using a computer random sequence method, with 80 patients included in each group.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient meets the diagnostic criteria for AMI in the "Diagnosis and Treatment Guidelines for Acute ST-Segment Elevation Myocardial Infarction (2019)" and undergoes PCI for the first time;
- •The age is between 18 and 75 years old;
- •The left ventricular ejection fraction (LVEF) is 35% - 50%;
- •The patient has normal cognition and can cooperate with the test;
- •The patient signs the informed consent and the agreement to participate in this study.
排除标准
- •Symptom-limited cardiopulmonary exercise test (treadmill) contraindications:
- •Uncontrolled acute coronary syndrome;
- •Acute heart failure;
- •Symptomatic severe aortic stenosis, severe aortic coarctation or descending aortic aneurysm;
- •Acute aortic dissection;
- •Acute myocarditis, pericarditis or endocarditis;
- •Symptomatic or hemodynamically unstable severe arrhythmia;
- •Severe bradyarrhythmia;
- •Acute pulmonary embolism and pulmonary infarction;
- •Acute respiratory failure;
- •Uncontrolled asthma;
- •Peripheral oxygen saturation < 88% at rest or heart rate > 120 beats/min;
- •s. Uncontrolled hypertension: systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg; t. Recent stroke or transient ischemic attack; u. Intermuscular venous thrombosis of the lower extremities; v. Orthopedic injury that hinders walking; w. Mental abnormality; x. Those who cannot cooperate;
- •Patients who have not completed revascularization treatment or have planned revascularization within one year;
- •Pregnant or lactating patients, or those who plan to become pregnant within one year;
- •Patients who have received mechanical circulatory support treatment (such as intra-aortic balloon counterpulsation, Impella, ECMO, etc.) or tracheal intubation;
- •Patients with a history of non-ischemic cardiomyopathy such as viral myocarditis or dilated cardiomyopathy, hypertrophic cardiomyopathy, peripartum cardiomyopathy, etc.;
- •Patients with moderate or severe valvular heart disease or a history of valve replacement;
- •Severe liver function abnormality (ALT ≥ 3 times the upper limit of the normal range) or renal function abnormality (eGFR < 60 mL/min/1.73 m2);
- •Patients with diseases such as malignant tumors and an expected lifespan of less than one year;
- •Those who cannot use a smartphone for various reasons and are inconvenient to communicate with the management team;
- •Those who are participating in other clinical trials;
- •The researcher believes that there are any other clinical conditions that are not suitable for inclusion in this study.
研究组 & 干预措施
Digitalized Cardiac Rehabilitation Group (Experimental Group)
Intervention group patients received in-hospital cardiac rehabilitation during their hospital stay and a digital cardiac rehabilitation program after discharge.
干预措施: digital cardiac rehabilitation (Behavioral)
Regular Treatment Group (Control Group)
The patients in the control group received in-hospital cardiac rehabilitation during their hospitalization, and after discharge, they conducted cardiac rehabilitation training at home by themselves and returned to the hospital for regular follow-up.
干预措施: Regular Treatment (Behavioral)
结局指标
主要结局
electrocardiogram
时间窗: 12 months
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 and activity levels.
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.
maximal oxygen uptake(VO2 max)
时间窗: 12 months
maximal oxygen uptake(VO2 max) is measured by Cardiopulmonary exercise testing (CPET). 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.
blood oxygen
时间窗: 12 months
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, sleep stages.
breathing patterns
时间窗: 12 months
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 breathing to evaluate breathing patterns, sleep breathing events, sleep stages.
The left ventricular ejection fraction ( LVEF)
时间窗: 12 months
The patient's left ventricular ejection fraction ( LVEF) is detected by echocardiography. The patient is in the supine position, and the probe scans the parasternal long-axis view of the left ventricle, the apical four-chamber view, the two-chamber view, the short-axis view of the ventricle, etc. The left ventricular ejection fraction ( LVEF) is determined. The value are obtained by calculating the average of three consecutive cardiac cycles in the apical four-chamber view using the modified Simpson's rule.
次要结局
- incidence rate of Major Adverse Cardiovascular Events (MACE)(12 months)
- Barthel Index(12 months)
- score of the Generalized Anxiety Disorder 7-item scale (GAD-7)(12 months)
- score of the Patient Health Questionnaire-9 (PHQ-9)(12 months)
研究者
Chen Leilei
Director
The First Affiliated Hospital with Nanjing Medical University