NCT06062316

Brief Summary

Acute myocardial infarction (AMI) is one of the most important diseases threatening human life. The existing MI prognosis prediction scales mostly predict the incidence of death, recurrent MI and heart failure through 6-8 clinical text indicators, and the data are collected relatively simply. Myocardial remodeling, as an adverse pathological change that can start and continue to progress in the early stage after myocardial infarction, is the main pathological mechanism of heart failure and death. However, there is no quantitative early-warning model of myocardial remodeling, and the clinical guidance of early intervention is lacking. Our previous study found that cardiac magnetic resonance imaging can accurately quantify the necrotic area and recoverable myocardium in the edematous myocardium after myocardial infarction. In this study, machine learning algorithm, variable convolution network (DCN) and capsule network (capsnet) are used to build a new neural network architecture. Structural feature extraction of multi-modal clinical image data such as MRI and ultrasound is realized. Combined with the established database of 3000 patients with myocardial infarction, the multimodal feature matrix will be constructed, and a variety of classifiers such as support vector machine (SVM) and random forest (RF) will be used for quantitative prediction of myocardial remodeling, and the effects of different classifiers were evaluated. It is expected that this project will establish a quantitative early warning model of myocardial remodeling after acute myocardial infarction in line with the characteristics of Chinese people. The same type of data outside the database will be used for verification to establish an efficient and stable early warning model.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 30, 2024

Status Verified

October 1, 2023

Enrollment Period

1.6 years

First QC Date

September 17, 2023

Last Update Submit

April 28, 2024

Conditions

Keywords

Computer aided diagnosisMyocardial RemodelingEarly warning modelMyocardial infarctionMRI

Outcome Measures

Primary Outcomes (1)

  • Novel convolutional neural network algorithm and cardiac magnetic resonance imaging to evaluate the occurrence of myocardial remodeling.remodeling after myocardial infarction.

    (Quantitative characterization of myocardial remodeling, cardiac magnetic resonance imaging quantifying necrotic areas and recoverable myocardium within the edematous myocardium after myocardial infarction).

    1year

Secondary Outcomes (1)

  • The multi-dimensional indexes of existing database were compared with the location and course of myocardial remodeling by artificial intelligence method Degree of correlation analysis.

    1year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Criteria for the diagnosis of acute myocardial infarction: increased or decreased cardiac biomarkers (preferably cTn), at least once exceeding the 99th percentile of the upper reference value, cut-off variability ≤10%, and at least one evidence of myocardial ischemia (including symptoms, electrocardiographic ischemic changes, pathological Q-waves, or imaging evidence).

You may qualify if:

  • Patients with acute myocardial infarction, aged 18-80 years; 2.The time from onset to treatment is less than 72h 3.Myocardial enzyme Tni/Tnt(+).

You may not qualify if:

  • Patients with malignant tumors; 2.Patients who could not receive conventional treatment 3.Patients who did not receive coronary angiography, lacking anatomical and imaging data; 4.Patients who have undergone cardiac surgery (except coronary artery bypass surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Xicheng, 100000, China

Location

Related Publications (25)

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MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Zhi Liu

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2023

First Posted

October 2, 2023

Study Start

October 10, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

April 30, 2024

Record last verified: 2023-10

Locations