Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy

Recruiting

• Conditions: Arrhythmogenic Cardiomyopathy
• Interventions: Other: Diagnosis of ACM

• Registration Number: NCT06352307
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

This study will include patients diagnosed with Arrhythmogenic cardiomyopathy (ACM) in the First Affiliated Hospital of Xi 'an Jiaotong University and other centers, and collect clinical data and biological samples of patients with different ACM phenotypes. Through the establishment of disease cohort and long-term follow-up, to explore the disease characteristics, development law, clinical characteristics, natural course of disease and long-term prognosis of ACM.

Detailed Description

This study will include patients diagnosed with Arrhythmogenic cardiomyopathy (ACM) in the First Affiliated Hospital of Xi 'an Jiaotong University and other centers, and collect clinical data and biological samples of patients with different ACM phenotypes. Through the establishment of disease cohort and long-term follow-up, to explore the disease characteristics, development law, clinical characteristics, natural course of disease and long-term prognosis of ACM.

Study Timeline

• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-08
• Study Start: 2024-04-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2030-08-31
• Study Completion: 2032-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Age >18 years old.
• The diagnosis of ACM was confirmed by cardiac ultrasound, electrocardiogram, magnetic resonance angiography, pathological examination and gene sequencing.
• Patients or their families agreed to participate in the study and authorized informed consent.

Exclusion Criteria

• Incomplete clinical data.
• Do not agree to the inclusion or refuse to authorize the informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Left ventricular ACM group	Diagnosis of ACM	The patients mainly had left ventricular enlargement and left ventricular fibroadipose tissue replacement, and were diagnosed with left ventricular ACM.
Right ventricular ACM group	Diagnosis of ACM	The patients mainly had right ventricular enlargement and right ventricular fibrous adipose tissue replacement, and were diagnosed with right ventricular ACM.
Biventricular ACM group	Diagnosis of ACM	The patients mainly had biventricular enlargement and fibroadipose tissue replacement, and were diagnosed with biventricular ventricular ACM.

Primary Outcome Measures

Name	Time	Method
Change in the incidence of mortality rate	At diagnosis, before discharge (about 7 days), 1, 3, 6, 9 month, 1, 2, 3 year.	The survival status will be obtained from the medical records and phone calls to patients or their family members.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiantong University; 🇨🇳 Xi'an, Shaanxi, China