Study Results
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Basic Information
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COMPLETED
148 participants
OBSERVATIONAL
2011-10-31
2019-09-30
Brief Summary
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Objectives: 1) To improve our understanding of the underlying pro-arrhythmic substrate and electrophysiologic mechanisms of VA in NICM, and to develop individualized treatment for VA based on the identified substrate. 2) To improve risk stratification for VA and sudden cardiac death in NICM based on substrate characteristics. 3) to evaluate disease progression in NICM.
Hypothesis: Improved understanding of the substrate and mechanisms of VA in NICM may allow more effective, individualized and substrate-based therapies to be developed.
Study design: A prospective cohort study.
Study population: The study population will consist of three groups (A, B and C): NICM patients with documented VA, suspected VA or intermediate to high risk for VA (according to established criteria) who are not referred for cardiac surgery (group A), NICM patients with documented VA, suspected VA or a high risk for VA who are referred for cardiac surgery (group B) and a control group consisting of patients without NICM who are referred for cardiac surgery (group C).
Evaluation: All patients will be evaluated according to current standards for patients with NICM. Evaluation will include 24h-Holter, echocardiography, coronary angiogram and contrast-enhanced MRI (CE-MRI). If CE-MRI is performed in another hospital, additional recordings will be performed in our hospital. Additionally, blood samples (arterial, cardiac venous and peripheral venous) for collagen turnover markers will be taken from all patients. 123-iodine metaiodobenzylguanidine (123-I MIBG) imaging, electrophysiologic study and endomyocardial biopsy will be performed in group A and B. Intra-operative biopsy will be performed in group B and C.
Intervention: In group B, intra-operative mapping and cryo-ablation and postoperative electrophysiologic study will be performed in patients with subepicardial late enhancement on MRI or induced VA suspected for an subepicardial origin.
Main study parameters/endpoints: The main study parameters are extent, location and pattern of fibrosis on imaging and in biopsy specimens. The main study endpoints are inducibility of VA, type of induced VA, spontaneous VA and type of spontaneous VA.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A: Nonischemic cardiomyopathy - not admitted for surgery
Patients with nonischemic cardiomyopathy with:
* documented ventricular arrhythmia or
* suspected ventricular arrhythmia (e.g. because of out-of-hospital cardiac arrest, palpitations or syncope) or
* high risk for ventricular arrhythmia (LVEF ≤ 35%) or
* intermediate risk for ventricular arrhythmia (LVEF ≤ 50% and late enhancement on contrast-enhanced MRI)
who are not admitted for cardiac surgery
Transthoracic echocardiography
Exercise test
24-hour Holter electrocardiogram
Contrast-enhanced magnetic resonance imaging
123-iodine metaiodobenzylguanidine imaging
Blood samples
Genetic analysis
Invasive electrophysiological study
Endomyocardial biopsy
Group B: Nonischemic cardiomyopathy -admitted for surgery
Patients with nonischemic cardiomyopathy with:
* documented ventricular arrhythmia or
* suspected ventricular arrhythmia (e.g. because of out-of-hospital cardiac arrest, palpitations or syncope) or
* high risk for ventricular arrhythmia (LVEF ≤ 35%)
who are admitted for cardiac surgery (e.g., mitral valve annuloplasty or CorCap)
Transthoracic echocardiography
Exercise test
24-hour Holter electrocardiogram
Contrast-enhanced magnetic resonance imaging
123-iodine metaiodobenzylguanidine imaging
Blood samples
Genetic analysis
Invasive electrophysiological study
Intraoperative biopsy
Intraoperative mapping and/or ablation
Group C: Controls
Patients without nonischemic cardiomyopathy (controls) who are admitted for:
* Coronary artery bypass graft surgery and who do not have prior myocardial infarction
* Aortic valve replacement
Transthoracic echocardiography
Exercise test
24-hour Holter electrocardiogram
Contrast-enhanced magnetic resonance imaging
Blood samples
Intraoperative biopsy
Interventions
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Transthoracic echocardiography
Exercise test
24-hour Holter electrocardiogram
Contrast-enhanced magnetic resonance imaging
123-iodine metaiodobenzylguanidine imaging
Blood samples
Genetic analysis
Invasive electrophysiological study
Endomyocardial biopsy
Intraoperative biopsy
Intraoperative mapping and/or ablation
Eligibility Criteria
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Inclusion Criteria
* Documented ventricular arrhythmia, suspected ventricular arrhythmia (e.g. because of out-of-hospital cardiac arrest, palpitations or syncope) or high risk for ventricular arrhythmias (LVEF ≤ 35%) or intermediate risk for ventricular arrhythmias (LVEF ≤ 50% and late enhancement on contrast-enhanced MRI)
* Admission not for cardiac surgery
* Nonischemic cardiomyopathy
* Documented ventricular arrhythmia or suspected ventricular arrhythmia (e.g. because of out-of-hospital cardiac arrest, palpitations or syncope) or high risk for ventricular arrhythmia (LVEF ≤ 35%)
* Admission for cardiac surgery (e.g., mitral valve annuloplasty or CorCap)
\- Patients undergoing aortic valve replacement or coronary artery bypass graft surgery
Exclusion Criteria
* Inadequate patient competence
* Pregnancy
* Inability to comply with the protocol due to haemodynamic instability
\- Other cardiomyopathy (e.g., prior myocardial infarction, infiltrative cardiac disease such as sarcoidosis, amyloidosis or Chagas cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, hypertrophic cardiomyopathy, non-compaction cardiomyopathy and congenital heart disease)
* Nonischemic cardiomyopathy
* Prior myocardial infarction
18 Years
80 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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Katja Zeppenfeld
Prof. dr.
Locations
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Dept. of Cardiology, Leiden University Medical Center
Leiden, , Netherlands
Countries
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References
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Piers SR, Androulakis AF, Yim KS, van Rein N, Venlet J, Kapel GF, Siebelink HM, Lamb HJ, Cannegieter SC, Man SC, Zeppenfeld K. Nonsustained Ventricular Tachycardia Is Independently Associated With Sustained Ventricular Arrhythmias in Nonischemic Dilated Cardiomyopathy. Circ Arrhythm Electrophysiol. 2022 Feb;15(2):e009979. doi: 10.1161/CIRCEP.121.009979. Epub 2022 Jan 28.
Other Identifiers
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Cardiomyopathy study
Identifier Type: -
Identifier Source: org_study_id
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