An observational study in Left Bundle-Branch Block, Electrocardiographic Pattens and Clinical Features, sponsored by Policlinico Casilino ASL RMB. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-06.
Sponsored by Policlinico Casilino ASL RMB · Observational
Clinical, structural and mechanical features in patients with left bundle branch block.
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.
94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.
This study's planned enrollment of 250 is above the median of 162 across 33 observational studies indexed under Bundle-Branch Block.
Browse Bundle-Branch Block studies →Policlinico Casilino ASL RMB is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
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In this prospective observational study we consider to enroll patients with LBBB admitted to our Cardiology Department and Ambulatory Care Unit recording different ECG patterns, risk factors, genetic, underlying heart disease, imaging parameters (Echocardiographic and Cardiac Magnetic Resonance) and treatment (either pharmacological or interventional).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rate of ECG pattern distribution in LBBB patients
Time frame: 5 years
Rate of underlying structural heart diseases in different LBBB pattern
Time frame: 5 years
Number of participants with stress induced myocardial ischemia during Stress Magnetic resonance
Time frame: 5 years
number or participants with late gadolinium enhancement during cardiac magnetic resonance
Time frame: 5 years
number and of participants with isolated LBBB evolving to dyssynchrony-related cardiomyopathy
Time frame: 5 years
Number of participants with mechanical dyssynchrony evaluated with Echocardiography
Strain, Strain Rate, intraventricular timing Delay between left ventricular lateral and Septal wall
Time frame: 5 years
No study locations are listed for this record.
Plan to share: No
Start is estimated for May 2020; primary completion for Apr 2022, 23 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Policlinico Casilino ASL RMB