Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy

NCT06352307 | Recruiting

• 1 other identifier: XJTU1AF2023LSK-532
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmogenic Cardiomyopathy

Keywords

Arrhythmogenic cardiomyopathy; Prognostic factors

Outcome Measures

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.

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

Study Arms (3)

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

Diagnosis of ACM 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; Left ventricular ACM group; Right ventricular ACM group

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Incomplete clinical data.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiantong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

For the retrospectively enrolled patients, we will collect their biological samples previously housed in the Biobank of The First Affiliated Hospital of Xi'an Jiaotong University. For the prospectively enrolled patients, we will collect a variety of biological samples at admission, before discharge, 1st, 3rd, 6th, 9th month, 1st, 2nd, 3rd year after discharge, including blood, urine, feces, other types of body fluids (such as pericardial effusion), tissue samples from surgery and biopsy (such as pericardial effusion, myocardial tissue, tumors, blood clots, etc.), or samples that need to be disposed of as medical waste (blood clots, etc.), or the sample itself requires pathological examination to assist in diagnosis and treatment (e.g. endocardial muscle biopsy).

Study Officials

• Yang Yan

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Yan

CONTACT

+86.29.85323869; yangyan3@xjtu.edu.cn

Guoliang Li

CONTACT

+86.29.85323869; liguoliang_med@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: April 9, 2024
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2032
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

CN (1)