Effect of Digital Therapeutics for Cardiac Rehabilitation in Patients With Acute Myocardial Infarction

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое digital cardiac rehabilitation
  Intra-hospital cardiac rehabilitation: For patients after PCI, reasonable dietary intervention, conventional drug treatment and conventional rehabilitation are given, without lower extremity power bike and respiratory training.Outside-hospital cardiac rehabilitation: The experimental group received conventional treatment and secondary prevention drugs recommended by the current guidelines, and carried out supervised digital cardiac rehabilitation on this basis.Doctors prescribe progressive aerob
• Поведенческое Regular Treatment
  Intra-hospital cardiac rehabilitation: For patients after PCI, reasonable dietary intervention, conventional drug treatment and conventional rehabilitation are given, without lower extremity power bike and respiratory training.Out-of-hospital cardiac rehabilitation: Receiving conventional treatment and secondary prevention drugs recommended by current guidelines, nutritional diet and lifestyle guidance, and establishing a WeChat group as a postoperative follow-up contact method.Outside-hospital

Первичные конечные точки

• 6-minute walk test (6MWT) [Срок оценки: 12 months]
• maximal oxygen uptake(VO2 max) [Срок оценки: 12 months]
• electrocardiogram [Срок оценки: 12 months]
• breathing patterns [Срок оценки: 12 months]
• blood oxygen [Срок оценки: 12 months]
• The left ventricular ejection fraction ( LVEF) [Срок оценки: 12 months]

Вторичные конечные точки (4)

• Barthel Index [Срок оценки: 12 months]
• score of the Generalized Anxiety Disorder 7-item scale (GAD-7) [Срок оценки: 12 months]
• score of the Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: 12 months]
• incidence rate of Major Adverse Cardiovascular Events (MACE) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• the First Affiliated Hospital of Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT06772337 · DTCR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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