Acute Myocardial InfarctionNCT06772337
Effect of Digital Therapeutics for Cardiac Rehabilitation in Patients With Acute Myocardial Infarction
A study testing digital cardiac rehabilitation and Regular Treatment in people with Acute Myocardial Infarction and Cardiac Rehabilitation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction, Cardiac Rehabilitation
- What is being tested?
- digital cardiac rehabilitation and Regular Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 23Show fewer
- 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;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
About this study
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
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.
Read the 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.
- Being tested
- digital cardiac rehabilitation, Regular Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital cardiac rehabilitationBehavioural
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 TreatmentBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Regular Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (4)
Barthel Index
Barthel Index: The ability of daily living self-care is evaluated by the Barthel Index, which consists of 10 items, including eating, bathing, grooming, dressing, bowel control, bladder control, toileting, transfer from bed to chair, walking, and going up and down stairs. The total score ranges from 0 to 100. The higher the score, the better the self-care ability. A score of 100 indicates complete self-care.
Measured: 12 months
score of the Generalized Anxiety Disorder 7-item scale (GAD-7)
Anxiety is assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). A total score of ≥5 in the assessment result is positive, indicating the possible presence of anxiety. Among them, a score of 5 - 9 may indicate mild anxiety, 10 - 14 may indicate moderate anxiety, and 15 - 21 may indicate severe anxiety.
Measured: 12 months
score of the Patient Health Questionnaire-9 (PHQ-9)
Depression is assessed using the Patient Health Questionnaire-9 (PHQ-9). A total score of ≥5 in the assessment result is positive, indicating the possible presence of depressive mood. Among them, a score of 5 - 9 may indicate mild depression, 10 - 14 may indicate moderate depression, and 15 - 27 may indicate severe depression.
Measured: 12 months
incidence rate of Major Adverse Cardiovascular Events (MACE)
Major Adverse Cardiovascular Events include heart failure, cardiovascular death, arrhythmia, atrial fibrillation, ventricular tachycardia, all-cause mortality, readmission, cardiogenic shock, target vessel revascularization, new or worsening myocardial infarction, non-fatal stroke, etc.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Leilei, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Xiangqing Kong, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772337
- Sponsor's protocol ID
- DTCR
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06772337
- Acronym / sponsor ID
- DTCR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digitalized Cardiac Rehabilitation Group (Experimental Group) | Experimental | Behavioral: digital cardiac rehabilitationIntervention group patients received in-hospital cardiac rehabilitation during their hospital stay and a digital cardiac rehabilitation program after discharge. |
| Regular Treatment Group (Control Group) | Experimental | Behavioral: Regular TreatmentThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- Symptom-limited cardiopulmonary exercise test (treadmill) contraindications:
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital cardiac rehabilitationIntra-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. | Behavioural | Digitalized Cardiac Rehabilitation Group (Experimental Group) |
| Regular TreatmentIntra-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. | Behavioural | Regular Treatment Group (Control Group) |
Primary outcome
6-minute walk test (6MWT)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiangqing Kong principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital cardiac rehabilitation and Regular Treatment in people with Acute Myocardial Infarction and Cardiac Rehabilitation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangqing Kong (13951610265, Chenlei19762002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (6MWT) (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.