Sponsor study identifier
observational
2,000
1 country
1
Study Start
October 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 10, 2024
Actual (reported)July 16, 2024
Actual (reported)October 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
The patients mainly had thickened myocardial wall with a thin, compacted epicardial layer and a thicker endocardial layer, and were diagnosed with LVNC.
The patients mainly had thickened myocardial wall with a thin, compacted epicardial layer and a thicker endocardial layer, and were diagnosed with right 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.
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.
Patients diagnosed with NVM at all centers including The First Affiliated Hospital of Xi'an Jiaotong University.
First Affiliated Hospital of Xi'an Jiantong University
Xi'an, Shaanxi, 710061, China
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).
Yang Yan
First Affiliated Hospital Xi'an Jiaotong University
First Submitted
July 10, 2024
First Posted
July 16, 2024
Study Start
October 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 1, 2027
EstimatedThe 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.
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.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 22, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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