Clinical trial NCT06767852: Risk Prediction Model of MACE in Patients With AMI Based on Multi-modal Machine Learning
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Myocardial Infarction
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 655
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 - 75 years old who have undergone PCI after acute myocardial infarction.

Brief 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.

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.

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.

Primary outcomes:
measure: 6-minute walk test (6MWT)
timeFrame: 12 months
measure: Cardiopulmonary exercise testing (CPET)
timeFrame: 12 months
measure: electrocardiogram
timeFrame: At the time of enrollment
measure: breathing and blood oxygen
timeFrame: At the time of enrollment
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 12 months
Secondary outcomes:
measure: Barthel Index
timeFrame: 12 months
measure: Left ventricular ejection fraction, LVEF
timeFrame: 12 months
measure: the assessment of the Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: 12 months
measure: the assessment of the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiangqing Kong
role: PRINCIPAL_INVESTIGATOR
References: