Risk Stratification and New Early Prevention and Treatment Strategies for Patients With Cardiomyopathy (STRENGTH）

NCT06352320 | Recruiting

• 1 other identifier: XJTU1AF2023LSK-533
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study will include patients with different types of cardiomyopathy from multiple centers were prospectively enrolled in a retrospective study to establish a natural population cohort of cardiomyopathy patients. By collecting clinical data and biological samples from surgical patients, we will construct a prognostic system for cardiomyopathy, optimize risk stratification, explore new strategies for the early prevention and treatment of cardiomyopathy, and improve the efficiency of clinical cardiomyopathy patients' diagnosis and treatment.

Conditions

Cardiomyopathies

Keywords

Cardiomyopathies; 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, 5, 10 year.

Study Arms (6)

HCM group

Patients were diagnosed with HCM.

Biological: Diagnosis of HCM

DCM group

Patients were diagnosed with DCM.

Biological: Diagnosis of DCM

ARVC group

Patients were diagnosed with ARVC.

Biological: Diagnosis of ARVC

NDLVC group

Patients were diagnosed with NDLVC.

Biological: Diagnosis of NDLVC

RCM group

Patients were diagnosed with RCM.

Biological: Diagnosis of RCM

LVNC group

Patients were diagnosed with LNVC.

Biological: Diagnosis of LVNC

Interventions

Diagnosis of HCM BIOLOGICAL

Hypertrophic cardiomyopathy (HCM) is defined as the presence of increased LV wall thickness (with or without RV hypertrophy) or mass that is not solely explained by abnormal loading conditions.

HCM group

Diagnosis of DCM BIOLOGICAL

Dilated cardiomyopathy (DCM) is defined as the presence of LV dilatation and global or regional systolic dysfunction unexplained solely by abnormal loading conditions (e.g. hypertension, valve disease, CHD) or CAD.Very rarely, LV dilatation can occur with normal ejection fraction (EF) in the absence of athletic remodelling or other environmental factors; this is not in itself a cardiomyopathy, but may represent an early manifestation of DCM. The preferred term for this is isolated left ventricular dilatation. Right ventricular dilatation and dysfunction may be present but are not necessary for the diagnosis.

DCM group

Diagnosis of ARVC BIOLOGICAL

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is defined as the presence of predominantly RV dilatation and/or dysfunction in the presence of histological involvement and/or electrocardiographic abnormalities in accordance with published criteria.

ARVC group

Diagnosis of NDLVC BIOLOGICAL

The NDLVC phenotype is defined as the presence of non-ischaemic LV scarring or fatty replacement regardless of the presence of global or regional wall motion abnormalities (RWMAs), or isolated global LV hypokinesia without scarring.

NDLVC group

Diagnosis of RCM BIOLOGICAL

Restrictive cardiomyopathy (RCM) is defined as restrictive left and/or RV pathophysiology in the presence of normal or reduced diastolic volumes (of one or both ventricles), normal or reduced systolic volumes, and normal ventricular wall thickness.Restrictive cardiomyopathy commonly presents as biatrial enlargement. Left ventricular systolic function can be preserved, but it is rare for contractility to be completely normal. Restrictive pathophysiology may not be present throughout the natural history, but only at an initial stage (with an evolution towards a hypokinetic-dilated phase). Restrictive physiology can also occur in patients with end-stage hypertrophic and dilated cardiomyopathy; the preferred terms are 'hypertrophic' or 'dilated cardiomyopathy with restrictive physiology'. Restrictive ventricular physiology can also be caused by endocardial pathology (fibrosis, fibroelastosis, and thrombosis) that impairs diastolic function

RCM group

Diagnosis of LVNC 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 thickerendocardial layer. 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 ventricular non-compaction has also been used to describe an acquired and sometimes transient phenomenon of excessive LV trabeculation (e.g. in athletes, during pregnancy, or following vigorous activity)that must reflect increased prominence of an otherwise normal myocardial architecture, given that cardiomyocytes are terminally differentiated and the formation of new cardiac structures is impossible.The Task Force does not consider LVNC to be a cardiomyopathy in the general sense.

LVNC group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age \>18 years old.
• The diagnosis of cardiomyopathy 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

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

For the retrospectively enrolled patients, we 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, we 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

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

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: April 2, 2024
• First Posted: April 8, 2024
• Study Start: May 9, 2024
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2032
• Last Updated: July 12, 2024

Record last verified: 2024-03

Locations

CN (1)