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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Isolated Noncompaction of the Ventricular Myocardium
• Intervention / Treatment: Biological: Diagnosis of NVM

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Yang Yan; Phone Number: +862985323869; Email: yangyan3@xjtu.edu.cn
• Study Contact Backup: Name: Guoliang Li; Phone Number: +862985323869; Email: liguoliang_med@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital of Xi'an Jiantong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Principal Investigator: Yang Yan, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Prognostic factors; Isolated Noncompaction of the Ventricular Myocardium
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Cardiomyopathies; Heart Defects, Congenital; Cardiovascular Abnormalities; Abnormalities, Multiple; Endocardial Fibroelastosis; Isolated Noncompaction of the Ventricular Myocardium
• Other Study ID Numbers: XJTU1AF2024LSYY-053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No