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

NCT06772337 | Not Yet Recruiting

• 1 other identifier: DTCR
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (6)

• 6-minute walk test (6MWT)

  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.

  12 months

• maximal oxygen uptake(VO2 max)

  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.

  12 months

• electrocardiogram

  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.

  12 months

• breathing patterns

  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.

  12 months

• blood oxygen

  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.

  12 months

• The left ventricular ejection fraction ( LVEF)

  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.

  12 months

Secondary Outcomes (4)

• 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

• incidence rate of Major Adverse Cardiovascular Events (MACE)

  12 months

Study Arms (2)

Digitalized Cardiac Rehabilitation Group (Experimental Group)

EXPERIMENTAL

Intervention group patients received in-hospital cardiac rehabilitation during their hospital stay and a digital cardiac rehabilitation program after discharge.

Behavioral: digital cardiac rehabilitation

Regular Treatment Group (Control Group)

EXPERIMENTAL

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.

Behavioral: Regular Treatment

Interventions

digital cardiac rehabilitation BEHAVIORAL

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.

Digitalized Cardiac Rehabilitation Group (Experimental Group)

Regular Treatment BEHAVIORAL

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.

Regular Treatment Group (Control Group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Study Officials

• Xiangqing Kong

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangqing Kong

CONTACT

13951610265; Chenlei19762002@163.com

Leilei Chen

CONTACT

18651856055; Chenlei19762002@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 13, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

CN (1)