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临床试验/NCT06146556
NCT06146556进行中(未招募)不适用

Concealed Myocardial Abnormalities by Cardiac Magnetic Resonance Imaging in Idiopathic Ventricular Arrhythmias

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Assess the diagnostic yield of cardiac MRI in early detection of biventricular dysfunction in patients with idiopathic VAs

研究概览

简要总结

Idiopathic Ventricular arrhythmia (VAs) refers to VAs that occur in the absence of clinically apparent structural heart disease. The outflow tracts (OTs) are the most common origin of idiopathic VAs and PVCs, accounting for approximately 10% of all patients referred for evaluation of VAs with the RVOT being the origin of about 70-80% of these arrhythmias.

Studies have shown that increased PVC burden was associated with reduced LV function, a higher incidence of heart failure, and a higher risk of death.

The diagnosis, prognostication and treatment of patients with VAs are challenging. A routine diagnostic workup that includes transthoracic echocardiography and an assessment for the presence of coronary artery disease (CAD) as recommended by current clinical guidelines cannot recognize focal structural abnormalities or underlying structural heart disease (SHD) in a substantial proportion of patients. Cardiac magnetic resonance (CMR) provides an excellent assessment of cardiac morphology and function and enables a detailed myocardial tissue characterization with a high degree of precision. CMR is widely regarded as the gold standard for identifying structural arrhythmogenic substrates in patients with VAs and normal echocardiography.

详细描述

Idiopathic Ventricular arrhythmia (VAs) refers to VAs that occur in the absence of clinically apparent structural heart disease. The outflow tracts (OTs) are the most common origin of idiopathic VT and PVCs, accounting for approximately 10% of all patients referred for evaluation of VT with the RVOT being the origin of about 70-80% of these arrhythmias.

Studies have shown that increased PVC burden was associated with reduced LV function, a higher incidence of heart failure, and a higher risk of death.

The diagnosis, prognostication and treatment of patients with VAs are challenging. A routine diagnostic workup that includes transthoracic echocardiography and an assessment for the presence of coronary artery disease (CAD) as recommended by current clinical guidelines cannot recognize focal structural abnormalities or underlying structural heart disease (SHD) in a substantial proportion of patients. Cardiac magnetic resonance (CMR) provides an excellent assessment of cardiac morphology and function and enables a detailed myocardial tissue characterization with a high degree of precision. CMR is widely regarded as the gold standard for identifying structural arrhythmogenic substrates in patients with VAs and normal echocardiography. More importantly, myocardial structural abnormalities detected on CMR in patients with idiopathic VAs are associated with an increased risk of arrhythmic events and worse clinical outcomes.

However, little is known regarding the added value of CMR including feature-tracking strain CMR (FT-CMR) in identifying underlying myocardial abnormalities and biventricular dysfunction in a relatively 'healthy' population of patients with VAs and normal echocardiography.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients presented with idiopathic ventricular arrhythmias with normal diagnostic routine workup at Assiut university heart hospital. Diagnostic work up including a normal ECG with no changes suggestive of structural heart disease, normal echocardiography findings and no evidence of CAD on either invasive or non-invasive imaging

排除标准

  • (1) known history of cardiac disease (CAD, cardiomyopathy, congenital heart disease, more than mild valvular disease, previous cardiac surgery of any type), any severe systemic disease with cardiac involvement.
  • (2) Allergy to gadolinium-based contrast agents, an estimated glomerular filtration rate < 30 mL/min/1.73 m
  • (3) Any contraindication to the MR environment (e.g., MR-unsafe implants/devices, shrapnel injury), pregnancy and claustrophobia

结局指标

主要结局

Assess the diagnostic yield of cardiac MRI in early detection of biventricular dysfunction in patients with idiopathic VAs

时间窗: one year

the value of CMR in evaluation of ventricular dysfunction in patients with ventricular arrhythmias

次要结局

  • Assess the PVCs burden association with myocardial abnormalities(one year)
  • Assess the PVCs morphology association with myocardial abnormalities(one year)
  • Assess the clinical predictors of myocardial dysfunction(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Abdallah Hasaballah Farag

Assistant lecturer

Assiut University

研究点 (1)

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