Clinical trial NCT06772337: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Myocardial Infarction
Cardiac Rehabilitation
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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:

  1. Uncontrolled acute coronary syndrome;
  2. Acute heart failure;
  3. Symptomatic severe aortic stenosis, severe aortic coarctation or descending aortic aneurysm;
  4. Acute aortic dissection;
  5. Acute myocarditis, pericarditis or endocarditis;
  6. Symptomatic or hemodynamically unstable severe arrhythmia;
  7. Severe bradyarrhythmia;
  8. Acute pulmonary embolism and pulmonary infarction;
  9. Acute respiratory failure;
  10. Uncontrolled asthma;
  11. 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.

Primary outcomes:
measure: 6-minute walk test (6MWT)
timeFrame: 12 months
measure: maximal oxygen uptake(VO2 max)
timeFrame: 12 months
measure: electrocardiogram
timeFrame: 12 months
measure: breathing patterns
timeFrame: 12 months
measure: blood oxygen
timeFrame: 12 months
measure: The left ventricular ejection fraction ( LVEF)
timeFrame: 12 months
Secondary outcomes:
measure: Barthel Index
timeFrame: 12 months
measure: score of the Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: 12 months
measure: score of the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 months
measure: incidence rate of Major Adverse Cardiovascular Events (MACE)
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiangqing Kong
role: PRINCIPAL_INVESTIGATOR
References: