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NCT Number: NCT06352307

Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy

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.

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Key information

Conditions

Arrhythmogenic Cardiomyopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Guoliang Li

CONTACT

[email protected]

+86.29.85323869

Yang Yan

CONTACT

[email protected]

+86.29.85323869

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Acronym: STARTER

Important dates

Study start
2024
Primary completion
2030
Study completion
2032
First posted
Apr 8, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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