The First Affiliated Hospital with Nanjing Medical University
Phase
Not applicable
Started
2025-03-01
Last updated
2025-01-13
Condition(s) studied
Acute Myocardial InfarctionCardiac Rehabilitation
Investigational drug(s) / intervention(s)
digital cardiac rehabilitationRegular Treatment
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 aerobic exercise (walking) through mobile phone apps or computer terminals. Patients will train with wearable devices that can monitor physiological parameters in real time through the mobile phone FREE Rehabilitation APP.
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 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 aerobic exercise (walking) through mobile phone apps or computer terminals. Patients will train with wearable devices that can monitor physiological parameters in real time through the mobile phone FREE Rehabilitation APP.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)
6-minute walk test (6MWT) — 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) — 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.
electrocardiogram — 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.
breathing patterns — 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.
blood oxygen — 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.
The left ventricular ejection fraction ( LVEF) — 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.
Trial sites (1)
Facility
City
Region
Status
the First Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangsu
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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