Risk Stratification and Early Preventio… | Clinical Trial

Key information

Conditions

Isolated Noncompaction of the Ventricular Myocardium Abnormalities, Multiple Cardiomyopathies Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocardial Fibroelastosis Genetic Diseases, Inborn Genetic Diseases, X-Linked Heart Defects, Congenital Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Xi'an Jiantong University

Xi'an, Shaanxi, 710061, China

About this study

This study intends to retrospectively-prospectively enroll NVM patients from multiple centers to establish a natural population cohort of NVM patients. By collecting clinical data and biological samples from surgical patients, the investigators will construct a prognosis prediction system for NVM, optimize risk stratification, explore new strategies for the early prevention and treatment of NVM, and improve the efficiency of clinical treatment of NVM patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The diagnosis of nvm 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 NVM

Biological

The term 'left ventricular non-compaction' (LVNC) has been used to describe a ventricular phenotype characterized by prominent LV trabeculae and deep intertrabecular recesses. The myocardial wall is often thickened with a thin,compacted epicardial layer and a thickened myocardial layer. In some patients, this abnormal trabecular architecture is associated with LV dilatation and systolic dysfunction. Left ventricular non-compaction is frequently a familial trait and is associated with variants in a range of genes, including those encoding proteins of the sarcomere, Z-disc, cytoskeleton, and nuclear envelope.

Primary outcomes

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]

+862985323869

Yang Yan

CONTACT

[email protected]

+862985323869

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

Risk Stratification and Early Prevention Strategies for Non-compaction of Ventricular Myocardium (CAPTAIN): a Multicenter, Retrospective-prospective, Cohort Study

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2030
First posted: Jul 16, 2024
Registry last updated: Jul 22, 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.

Published trials that share one or more normalized conditions with this study.

Completed