Risk Stratification and Early Prevention Strategies for Non-compaction of Ventricular Myocardium (CAPTAIN)

NCT06504056 | Not Yet Recruiting

• 1 other identifier: XJTU1AF2024LSYY-053
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Isolated Noncompaction of the Ventricular Myocardium

Keywords

Isolated Noncompaction of the Ventricular Myocardium; 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)

Left ventricle group

The patients mainly had thickened myocardial wall with a thin, compacted epicardial layer and a thicker endocardial layer, and were diagnosed with LVNC.

Biological: Diagnosis of NVM

Right ventricle group

The patients mainly had thickened myocardial wall with a thin, compacted epicardial layer and a thicker endocardial layer, and were diagnosed with right NVM.

Biological: Diagnosis of NVM

Two sided ventricle group

The patients mainly had thickened myocardial wall with a thin, compacted epicardial layer and a thicker endocardial layer, and were diagnosed with right and left ventricle NVM.

Biological: Diagnosis of NVM

Interventions

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.

Left ventricle group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

For the retrospectively enrolled patients, the investigators 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, the investigators 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).

MeSH Terms

Conditions

Isolated Noncompaction of the Ventricular Myocardium

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Endocardial Fibroelastosis; Cardiomyopathies; Heart Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked; Genetic Diseases, Inborn

Study Officials

• Yang Yan

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Yan

CONTACT

+862985323869; yangyan3@xjtu.edu.cn

Guoliang Li

CONTACT

+862985323869; 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: July 10, 2024
• First Posted: July 16, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

CN (1)