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

NCT06767852 | Not Yet Recruiting

• 1 other identifier: MPAMI
• Study Type: observational
• Target: 655
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (5)

• 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

• 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.

  12 months

• 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.

  At the time of enrollment

• 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.

  At the time of enrollment

• 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.

  12 months

Secondary Outcomes (4)

• Barthel Index

  12 months

• Left ventricular ejection fraction, LVEF

  12 months

• the assessment of the Generalized Anxiety Disorder 7-item scale (GAD-7)

  12 months

• the assessment of the Patient Health Questionnaire-9 (PHQ-9)

  12 months

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

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; kongxq@njmu.edu.cn

Leilei Chen

CONTACT

18651856055; Chenlei19762002@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 10, 2025
• Study Start: March 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

CN (1)