Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy

NCT ID: NCT06352307

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-09

Study Completion Date

2032-08-31

Brief Summary

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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

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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.

Conditions

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Arrhythmogenic Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Diagnosis of ACM

Intervention Type OTHER

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.

Left ventricular ACM group

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

Diagnosis of ACM

Intervention Type OTHER

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.

Biventricular ACM group

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

Diagnosis of ACM

Intervention Type OTHER

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.

Interventions

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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 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yang Yan

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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First Affiliated Hospital of Xi'an Jiantong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Yan

Role: CONTACT

+86.29.85323869

Guoliang Li

Role: CONTACT

+86.29.85323869

Facility Contacts

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Guoliang Li

Role: primary

+86.29.85323869

Yang Yan

Role: backup

+86.29.85323869

Other Identifiers

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XJTU1AF2023LSK-532

Identifier Type: -

Identifier Source: org_study_id

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