Skeletal Muscle Multi-omics Analysis and Risk Tailoring in Sudden Cardiac Death

NCT07476456 | Not Yet Recruiting DMC

• 2 other identifiers: 2026-30392025-I2MCT-B-030
• Study Type: observational
• Target: 421
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sudden Cardiac Death

Keywords

Sarcopenia; Skeletal Muscle Metabolism; Ventricular Arrhythmia; Multimodal Predictive Model; Sudden cardiac death

Outcome Measures

Primary Outcomes (1)

• Composite ventricular arrhythmia (VA) events

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

  12 months

Secondary Outcomes (1)

• All-cause mortality

  12 months

Eligibility Criteria

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

Study Population

patients receiving implantable cardioverter defibrillator (ICD) implantation

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Beilishi Road 167

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (3)

• Damluji AA, Alfaraidhy M, AlHajri N, Rohant NN, Kumar M, Al Malouf C, Bahrainy S, Ji Kwak M, Batchelor WB, Forman DE, Rich MW, Kirkpatrick J, Krishnaswami A, Alexander KP, Gerstenblith G, Cawthon P, deFilippi CR, Goyal P. Sarcopenia and Cardiovascular Diseases. Circulation. 2023 May 16;147(20):1534-1553. doi: 10.1161/CIRCULATIONAHA.123.064071. Epub 2023 May 15.

  PMID: 37186680 BACKGROUND

• Sayer AA, Cooper R, Arai H, Cawthon PM, Ntsama Essomba MJ, Fielding RA, Grounds MD, Witham MD, Cruz-Jentoft AJ. Sarcopenia. Nat Rev Dis Primers. 2024 Sep 19;10(1):68. doi: 10.1038/s41572-024-00550-w.

  PMID: 39300120 BACKGROUND

• Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.

  PMID: 36017572 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Baseline blood and urine samples; skeletal muscle tissue at the pocket site

MeSH Terms

Conditions

Death, Sudden, Cardiac; Sarcopenia

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Central Study Contacts

Xiaoyao Li, PhD

CONTACT

+86 01088322295; fwlxy2015@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arrhythmia Center Attending Physician

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CN (1)