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临床试验/NCT07476456
NCT07476456尚未招募不适用

Development and Implementation of an Artificial Intelligence-Driven Multimodal Skeletal Muscle Feature Fusion Model for Risk Prediction of Sudden Cardiac Death in Patients With Implantable Cardioverter-Defibrillators: The SMART-SCD Study.

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 421 人开始时间: 2026年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
421
试验地点
1
主要终点
Composite ventricular arrhythmia (VA) events

研究概览

简要总结

This study is designed as a prospective, single-center, observational cohort study (the SMART-SCD Study, full name: Skeletal Muscle Multi-omics Analysis and Risk Tailoring in Sudden Cardiac Death), which enrolls high-risk populations meeting the criteria for implantable cardioverter defibrillator (ICD) implantation.

The research focuses on the mechanistic association between skeletal muscle metabolic disorders and ventricular arrhythmia (VA) as well as sudden cardiac death (SCD), and aims to construct a "muscle-heart crosstalk" risk early warning system through integration of multimodal skeletal muscle data. We will systematically collect the following data:

Baseline handgrip strength measurement (Biomi-h500+X5); Functional diagnosis and phenotyping of sarcopenia conducted via the InBody 270 body composition analyzer; Non-contrast chest and abdominal computed tomography (CT) images (to extract novel imaging phenotypes including skeletal muscle density at the T12 vertebra level, intermuscular adipose tissue, subcutaneous adipose tissue, etc.); Serum biomarkers (GDF-8, Irisin, IL-6); Metabolomics data of skeletal muscle tissue from the ICD pocket (lipid/energy metabolism profiles detected via the UPLC-QTOF/MS platform); Ambulatory electrocardiographic data. All treatment and intervention regimens for patients will be independently formulated by clinicians in accordance with clinical guidelines, and the study itself does not involve any intervention measures. Prospective follow-up will be conducted at 3/6/12 months after ICD implantation. The primary endpoint is composite ventricular arrhythmia events (including SCD, appropriate ICD therapy documented by the device, and hemodynamically unstable ventricular tachycardia/ventricular fibrillation), and the secondary endpoint is all-cause mortality.

Through the above prospective cohort study, we will integrate multimodal data including novel CT imaging phenotypes of skeletal muscle, metabolomics profiles and functional phenotyping of sarcopenia using artificial intelligence techniques, so as to construct a precision prediction model for SCD, screen novel CT imaging phenotypes of sarcopenia and myogenic metabolites, and finally establish a generalizable SCD risk assessment tool and individualized intervention strategies.

详细描述

  1. Study Design This is a prospective, single-center, observational cohort study (the SMART-SCD Study, full name: Skeletal Muscle Multi-omics Analysis and Risk Tailoring in Sudden Cardiac Death). All treatments administered to enrolled patients will be independently determined by clinicians based on individual patient conditions. This study does not involve any interventional therapeutic measures, and only collects multimodal data via observational procedures.
  2. Study Population Study subjects are patients receiving implantable cardioverter defibrillator (ICD) implantation at [Name of Hospital] who meet all inclusion criteria and do not meet any of the exclusion criteria.

Inclusion Criteria:

Undergoing first-time ICD implantation (including cardiac resynchronization therapy defibrillator, CRT-D implantation); Completed multi-dimensional sarcopenia assessment at baseline; Willing to receive prospective follow-up and signed the informed consent form (ICF).

Exclusion Criteria:

History of valvular heart disease (e.g., mitral stenosis, history of heart valve replacement or valvuloplasty, etc.); Implanted ICD type is subcutaneous ICD (S-ICD) or extra-vascular ICD (EV-ICD); Concomitant comorbidities affecting muscle metabolism, such as malignant tumors, severe liver or kidney disease, etc. 3. Study Duration Enrollment period: Planned to complete enrollment of all subjects within 12 months after study initiation.

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

  • Undergoing first-time ICD implantation (including cardiac resynchronization therapy defibrillator, CRT-D implantation);
  • Completed multi-dimensional sarcopenia assessment at baseline;
  • Willing to receive prospective follow-up and signed the informed consent form (ICF)

排除标准

  • History of valvular heart disease (e.g., mitral stenosis, history of heart valve replacement or valvuloplasty, etc.);
  • Implanted ICD type is subcutaneous ICD (S-ICD) or extra-vascular ICD (EV-ICD);
  • Concomitant comorbidities affecting muscle metabolism, such as malignant tumors, severe liver or kidney disease, etc.

结局指标

主要结局

Composite ventricular arrhythmia (VA) events

时间窗: 12 months

including sudden cardiac death (SCD), appropriate ICD therapy documented by the device, and hemodynamically unstable ventricular tachycardia (VT)/ventricular fibrillation (VF)

次要结局

  • All-cause mortality(12 months)

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Xiaoyao Li

Arrhythmia Center Attending Physician

China National Center for Cardiovascular Diseases

研究点 (1)

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