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RecruitingNCT06352307STARTERUpdated Jul 12, 2024

Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy

An observational study in Arrhythmogenic Cardiomyopathy, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Arrhythmogenic Cardiomyopathy

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Keywords

  • Arrhythmogenic cardiomyopathy
  • Prognostic factors
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 153 across 515 observational studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with ACM at all centers including The First Affiliated Hospital of Xi'an Jiaotong University.

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

Exclusion Criteria:

  • Incomplete clinical data.
  • Do not agree to the inclusion or refuse to authorize the informed consent.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Right ventricular ACM group

    The patients mainly had right ventricular enlargement and right ventricular fibrous adipose tissue replacement, and were diagnosed with right ventricular ACM.

    Other: Diagnosis of ACM

  • Left ventricular ACM group

    The patients mainly had left ventricular enlargement and left ventricular fibroadipose tissue replacement, and were diagnosed with left ventricular ACM.

    Other: Diagnosis of ACM

  • Biventricular ACM group

    The patients mainly had biventricular enlargement and fibroadipose tissue replacement, and were diagnosed with biventricular ventricular ACM.

    Other: Diagnosis of ACM

Interventions

  • OtherDiagnosis 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 abnormalities and an abnormal ventricular volume or function are required for fulfilment. Definite ACM consists of two major criteria or one major and two minor criteria or four minor criteria from different categories. Borderline ACM consists of one major and one minor criterion or three minor criteria from different categories.

06

What researchers measure

Primary outcomes

  1. Change in the incidence of mortality rate

    The survival status will be obtained from the medical records and phone calls to patients or their family members.

    Time frame: At diagnosis, before discharge (about 7 days), 1, 3, 6, 9 month, 1, 2, 3 year.

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Xi'an Jiantong University
    Xi'an, Shaanxi 710061, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06352307
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Apr 8, 2024
Start date
Apr 9, 2024
Primary completion
Aug 31, 2030 (estimated)
Completion
Aug 31, 2032 (estimated)
Last update
Jul 12, 2024

Study contacts

Yang Yan
Contact
yangyan3@xjtu.edu.cn
+86.29.85323869
Guoliang Li
Contact
liguoliang_med@163.com
+86.29.85323869
Yang Yan
principal investigator · First Affiliated Hospital Xi'an Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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