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

Not yet recruiting

• Conditions: Isolated Noncompaction of the Ventricular Myocardium
• Interventions: Biological: Diagnosis of NVM

• Registration Number: NCT06504056
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-16
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22
• Study Start: 2024-10-30
• Primary Completion: 2027-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Two sided ventricle group	Diagnosis of NVM	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.
Left ventricle group	Diagnosis of NVM	The patients mainly had thickened myocardial wall with a thin, compacted epicardial layer and a thicker endocardial layer, and were diagnosed with LVNC.
Right ventricle group	Diagnosis of NVM	The patients mainly had thickened myocardial wall with a thin, compacted epicardial layer and a thicker endocardial layer, and were diagnosed with right NVM.

Primary Outcome Measures

Name	Time	Method
Change in the incidence of mortality rate	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.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiantong University; 🇨🇳 Xi'an, Shaanxi, China