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Recruiting NCT06352307

Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy

Observational Arrhythmogenic Cardiomyopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diagnosis of ACM.
Who it may be relevant to
Registry conditions: Arrhythmogenic Cardiomyopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy (STARTER): a Multicenter Retro-prospective Cohort Study

Overview

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.

Interventions

  • Other Diagnosis of ACM
    Definite ACM diagnosis is based on the consensus-based 2010 Task Force Criteria, which include major and minor criteria in six categories (depolarization and repolarization abnormalities, arrhythmia, imaging, histology, and family history/genetics). Among these, repolarization abnormalities (T-wave inversion in the precordial leads) constitute the most commonly observed, followed by frequent premature ventricular complex. With regards to imaging techniques, both the presence of wall motion abnor

Primary outcome measures

  • Change in the incidence of mortality rate [Time frame: At diagnosis, before discharge (about 7 days), 1, 3, 6, 9 month, 1, 2, 3 year.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • First Affiliated Hospital of Xi'an Jiantong University — Xi'an

Identifiers

NCT: NCT06352307 · XJTU1AF2023LSK-532

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗