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Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06352307
Acronym
STARTER
Enrollment
1500
Registered
2024-04-08
Start date
2024-04-09
Completion date
2032-08-31
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmogenic Cardiomyopathy

Keywords

Arrhythmogenic cardiomyopathy, Prognostic factors

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.

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

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.

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in the incidence of mortality rateAt 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.

Countries

China

Contacts

Primary ContactYang Yan
yangyan3@xjtu.edu.cn+86.29.85323869
Backup ContactGuoliang Li
liguoliang_med@163.com+86.29.85323869

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026