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临床试验/NCT07527715
NCT07527715招募中不适用

Study on Risk Early Warning of Clinical Prediction Model Based on Multi-Parameter Stress Perfusion Cardiac Magnetic Resonance in Adverse Prognosis of Dilated Cardiomyopathy

Shandong Provincial Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
1
主要终点
SCD-related events

研究概览

简要总结

Dilated cardiomyopathy (DCM) is a common and serious heart disease characterized by left ventricular enlargement and impaired pumping function, with adverse prognosis (including heart failure, arrhythmia, heart-related hospitalization, and death) being a major concern for patients. Currently, a critical gap exists in accurately predicting which DCM patients are at high risk of these severe outcomes, limiting targeted clinical care.

This observational, non-invasive study aims to develop and validate a clinical prediction model for early risk warning of adverse prognosis in DCM patients. The model integrates multi-parameter stress perfusion cardiac magnetic resonance (MP stress perfusion CMR)-a safe, high-resolution imaging technique that assesses cardiac structure, function, blood perfusion, and tissue damage under mild stress-and standard clinical data (e.g., age, gender, blood pressure, and routine heart test results).

The model will be trained and tested using follow-up data from hundreds of DCM patients, with the analysis identifying patterns in CMR and clinical data associated with adverse outcomes. Once validated for accuracy, the model will provide doctors with personalized risk scores to prioritize care for high-risk patients (e.g., early intervention, close monitoring) and avoid over-treatment for lower-risk individuals.

Beyond clinical application, the study will enhance understanding of DCM progression, laying the groundwork for improved diagnostic tools, more effective treatments, and better strategies to prevent DCM-related complications, ultimately improving patient quality of life and reducing mortality.

详细描述

The study focuses on a common but serious heart condition called dilated cardiomyopathy (DCM), which affects millions of people worldwide. Dilated cardiomyopathy is a disease where the heart's main pumping chamber (the left ventricle) becomes enlarged and weakened, making pumping function harder for the heart to pump blood efficiently to the rest of the body. For patients with DCM, the biggest concern is the risk of "adverse prognosis"-a category includes serious outcomes like heart failure, abnormal heart rhythms, hospitalizations related to heart problems, or even death. Currently, doctors face challenges in accurately predicting which DCM patients are more likely to experience these severe outcomes, a limitation restricting the ability to provide timely, targeted care to those at highest risk.

To address the gap, the investigators aim to develop and test a "clinical prediction model"-a tool that combines medical data to predict the likelihood of adverse outcomes in DCM patients. The key innovation of the model is the use of a powerful medical imaging technique called multi-parameter stress perfusion cardiac magnetic resonance (MP stress perfusion CMR), combined with standard clinical information about patients.

First, the terms are explained in simple language. Cardiac magnetic resonance (CMR) is a safe, non-invasive imaging test that creates detailed pictures of the heart's structure and function. "Stress perfusion" means that during the CMR scan, the participant's heart is placed under a mild form of stress (usually by administration of a medication that increases heart rate, similar to light exercise) to observe blood flow through the heart muscle during increased workload. "Multi-parameter" refers to the collection of multiple types of information from the CMR scan, such as myocardial contractility, myocardial perfusion, and any damage or scarring in cardiac tissue.

The goal of the study is to use detailed CMR data, along with other basic clinical information (e.g., patient age, gender, blood pressure, and results from standard heart tests), to construct a prediction model. The model will be trained using data from hundreds of DCM patients with existing follow-up records. The investigators will analyze the records to determine which patients experienced adverse outcomes and to identify patterns in CMR and clinical data associated with those outcomes.

Once the model is constructed and tested for accuracy, the tool can be utilized by doctors in clinical practice to assist in the assessment of DCM patients. For example, when a patient is diagnosed with DCM, doctors can perform the CMR scan, input the data into the model, and obtain a personalized risk score indicating the probability of future severe cardiac events in that patient. The resulting information will support clinical decision-making: the scores will allow doctors to prioritize care for high-risk patients-such as early treatment initiation, more frequent monitoring, or medication adjustment-to prevent adverse outcomes. For lower-risk patients, the model can help avoid unnecessary, costly tests or over-treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.An elevated left ventricular end-diastolic volume indexed to body surface area and reduced LVEF, compared with published age- and gender-specific reference values

排除标准

  • significant coronary artery disease (CAD), defined as a stenosis of ˃50% in a major coronary artery
  • infiltrative disease
  • valvular cardiomyopathy
  • arrhythmogenic cardiomyopathy
  • congenital heart disease

结局指标

主要结局

SCD-related events

时间窗: 1 year, 3 years, and 5 years after CMR examination

SCD, appropriate implantable cardioverter-defibrillator shock, and resuscitated cardiac arrest

次要结局

  • heart failure events(at 1, 3, and 5 years following CMR)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Wenxian Wang

Principal Investigator

Shandong Provincial Hospital

研究点 (1)

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