Risk Prediction Model of MACE in Patients With AMI Based on Multi-modal Machine Learning
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Myocardial Infarction. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Primary outcome measures
- 6-minute walk test (6MWT) [Time frame: 12 months]
- Cardiopulmonary exercise testing (CPET) [Time frame: 12 months]
- electrocardiogram [Time frame: At the time of enrollment]
- breathing and blood oxygen [Time frame: At the time of enrollment]
- Major Adverse Cardiovascular Events (MACE) [Time frame: 12 months]
Secondary outcome measures (4)
- Barthel Index [Time frame: 12 months]
- Left ventricular ejection fraction, LVEF [Time frame: 12 months]
- the assessment of the Generalized Anxiety Disorder 7-item scale (GAD-7) [Time frame: 12 months]
- the assessment of the Patient Health Questionnaire-9 (PHQ-9) [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- the First Affiliated Hospital of Nanjing Medical University — Nanjing
Identifiers
NCT: NCT06767852 · MPAMI