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Not yet recruitingNCT06504056Updated Jul 22, 2024

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

An observational study in Isolated Noncompaction of the Ventricular Myocardium, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-07-22.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Isolated Noncompaction of the Ventricular Myocardium

Keywords

  • Isolated Noncompaction of the Ventricular Myocardium
  • Prognostic factors
03

In context

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Incomplete clinical data.
  • Do not agree to the inclusion or refuse to authorize the informed consent.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • BiologicalDiagnosis 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.

  • BiologicalDiagnosis 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.

  • BiologicalDiagnosis 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.

06

What researchers measure

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.

    Time frame: At diagnosis, before discharge (about 7 days), 1, 3, 6, 9 month, 1, 2, 3 year.

07

Study locations

1 site
  • First Affiliated Hospital of Xi'an Jiantong University
    Xi'an, Shaanxi 710061, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06504056
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Jul 16, 2024
Start date
Oct 30, 2024 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2030 (estimated)
Last update
Jul 22, 2024

Study contacts

Yang Yan
Contact
yangyan3@xjtu.edu.cn
+862985323869
Guoliang Li
Contact
liguoliang_med@163.com
+862985323869
Yang Yan
principal investigator · First Affiliated Hospital Xi'an Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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