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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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
• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (4)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• the First Affiliated Hospital of Nanjing Medical University — Nanjing

Identifiers

NCT: NCT06772337 · DTCR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗