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临床试验/NCT04328649
NCT04328649尚未招募不适用

Clinical, Structural and Mechanical Features in Patients With Left Bundle Branch Block: an Observational and Prospective Study.

Policlinico Casilino ASL RMB0 个研究点目标入组 250 人开始时间: 2020年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
250
主要终点
Rate of ECG pattern distribution in LBBB patients

研究概览

简要总结

Clinical, structural and mechanical features in patients with left bundle branch block.

详细描述

Left bundle-branch block (LBBB) is an electrocardiographic marker often associated with underlying cardiac disease (such as coronary artery disease, dilated cardiomyopathy, etc) but in some cases it is also found in patients with isolated LBBB defined as "none apparent structural heart disease".

Several investigations in animal and human study have showed a different electroanatomical activation in isolated LBBB when compared to LBBB in heart failure patients mostly due to coronary artery disease. The sequence of endocardial activation through the left ventricle has also proven to be heterogeneous in heart failure occuring at different septal regions. This electrical and mechanical variability seems to be related to location of LBBB block or lesion that could be proximal, distal or diffuse, consequently influencing also electrocardiographic aspects.

These considerations explain and justify the great variability in the proposed "true or typical LBBB" definitions (derived from from Strauss, Perrin and Marican definitions and from Heart Association/American College Cardiology Foundation/ European Society of Cardiology guidelines) but also shift attention to relatively new concept of atypical LBBB definitions with extreme left or right axis deviation and of non specific intraventricular conduction delay defined as a wide QRS (≥110 ms) without the appearance of left and right bundle-branch block. In fact, several investigations have shown that QRS axis deviation is a predictor of unfavorable outcome after cardiac resynchronization therapy and LBBB. The less favorable outcome of cardiac resynchronization therapy candidates with LBBB and left axis deviation seems to be associated to the presence of a shorter activation delay, scar tissue and left ventricular hypertrophy. Moreover, actual LBBB definitions recommended by guidelines in cardiac resynchronization therapy patients differ significantly and only individual ECG criteria (such as electrocardiographic intervals QS or RS in lead V1, notch and no q wave in lead V5, V6, I and avL) seems to be associated to clinical outcome when compared with combining criteria.

Finally, a frequent dyssynchrony of ventricular activation due to LBBB may be responsible for a dyssynchrony-related cardiomyopathy that needs to be identified early and differentiated from other forms of dilated cardiomyopathy through a multiparametric approach such as genetic, clinical data, electrocardiography and cardiac magnetic resonance. In fact, in isolated LBBB undergone cardiac magnetic resonance it was observed a greater left ventricular volumes and lower global left ventricular Ejection Fraction despite the absence of cardiovascular disease as compared with control subject. Despite this, comparison between isolated LBBB and structural heart disease shows a different myocardial mechanism all the more unfavourable the more significant is the presence of underlying myocardial scarring. In the other hand, isolated LBBB, dyssynchrony-related cardiomyopathy and myocardial scarring could present different temporal phase in the clinical history of the same patient and that must be early identified.

The aim of this present large-scale prospective observational study is to evaluate 1) clinical, electrocardiographic and imaging features in a population of patients with typical and atypical LBBB and " non specific intraventricular conduction delay" pattern during a long-term follow up and 2) association among eventual different LBBB patterns (typical, atypical (LBBB and extreme left and/or right axis deviation, fragmentation) and " non specific intraventricular conduction delay " pattern and tissue characterization, mechanical myocardial activation and perfusion. 3) a possible time-related evolution from "non specific intraventricular conduction delay" patterns to typical or atypical LBBB.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Every patient with electrocardiographic diagnosis of LBBB admitted to our Cardiology Department and Ambulatory Care Unit
  • ECG standard criteria from typical, atypical and NIVCD
  • Patients who have given their informed consent in writing.
  • Age ≥ 18 years

排除标准

  • Age <18 years
  • Patients who have not given their informed consent in writing.

结局指标

主要结局

Rate of ECG pattern distribution in LBBB patients

时间窗: 5 years

Rate of underlying structural heart diseases in different LBBB pattern

时间窗: 5 years

Number of participants with stress induced myocardial ischemia during Stress Magnetic resonance

时间窗: 5 years

number or participants with late gadolinium enhancement during cardiac magnetic resonance

时间窗: 5 years

number and of participants with isolated LBBB evolving to dyssynchrony-related cardiomyopathy

时间窗: 5 years

Number of participants with mechanical dyssynchrony evaluated with Echocardiography

时间窗: 5 years

Strain, Strain Rate, intraventricular timing Delay between left ventricular lateral and Septal wall

次要结局

未报告次要终点

研究者

发起方
Policlinico Casilino ASL RMB
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leonardo Calò, MD

Professor, FESC

Policlinico Casilino ASL RMB

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