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Acute Myocardial InfarctionNCT06767852

Risk Prediction Model of MACE in Patients With AMI Based on Multi-modal Machine Learning

An observational study of Acute Myocardial Infarction, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

A prospective, multicenter, observational study is adopted, 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
How many people
655 participants
Where
1 siteChina
Study dates
1 Mar 2025to 1 Dec 2026
Phase
Observational
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

Study population: Patients aged 18 - 75 years old who have undergone PCI after acute myocardial infarction.

Who may be able to join

  • Meeting the diagnostic criteria of AMI;
  • Ages 18 - 75 years old;
  • Meeting the indications for emergency PCI surgery, with informed consent and voluntarily undergoing PCI treatment; ④ Accurate and complete clinical relevant data; ⑤ First diagnosis and treatment; ⑥ All patients were given unified antiplatelet therapy after the operation; ⑦ All patients were followed up for 12 months after the operation.

Who cannot join

  • With malignant tumors, infections and other diseases;
  • Blood diseases, immune system diseases, severe liver and kidney function disorders; ③ With other heart diseases such as heart failure; ④ Patients undergoing surgical treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiangqing Kong contact

13951610265

kongxq@njmu.edu.cn

Leilei Chen contact

18651856055

Chenlei19762002@163.com

China1 site

  • the First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

Other trials in China

About this study

Official title: the Risk Prediction Model of MACE After PCI in Patients With AMI Based on Multimodal Machine Learning and the Effect of Digital Therapeutics for Cardiac Rehabilitation

A prospective, multicenter, observational study is adopted, with Jiangsu Provincial People's Hospital as the leading unit, and the other 13 Hospitals as cooperative units.

Read the detailed description

The deployment of an integrated cardiac rehabilitation management platform from the hospital to the outside of the hospital is uniformly arranged, and based on this platform, a study on the construction of a MACE prediction model and disease risk stratification for patients with acute myocardial infarction after PCI is carried out. It is planned to include 655 inpatients after PCI for acute myocardial infarction. Among them, the leading unit completes the enrollment and follow-up of 44 patients, and each cooperative unit completes the enrollment and follow-up of 47 patients, and competitive enrollment is allowed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Cardiopulmonary exercise testing (CPET)

    Cardiopulmonary exercise testing (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

  3. electrocardiogram

    24-hour physiological data monitoring: 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.

    Measured: At the time of enrollment

  4. breathing and blood oxygen

    24-hour physiological data monitoring: 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 and sleep stagess.

    Measured: At the time of enrollment

  5. Major Adverse Cardiovascular Events (MACE)

    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

Secondary outcomes (4)

  1. 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

  2. Left ventricular ejection fraction, LVEF

    The patient's cardiac function 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)are determined. The value is 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

  3. the assessment 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

  4. the assessment 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
655 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06767852
Sponsor's protocol ID
MPAMI
Status last verified
Jan 2025
First submitted
30 Dec 2024
Last updated
10 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction, 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 3 inclusion and 2 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 10 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, kongxq@njmu.edu.cn), 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 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06767852.

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 10 Jan 2025.

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