Noninvasive Electrocardiographic Imaging for Individuals at Risk for Apparently Idiopathic Ventricular Fibrillation.

NCT03963271 | Unknown DMC

• 1 other identifier: NL67079.068.18
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to evaluate the electrophysiological properties of the heart conduction system in patients with unexplained polymorphic ventricular tachycardia (VT) and/or ventricular fibrillation (VF), in patients with specific genetic mutations regarding sudden cardiac death or sudden cardiac arrest, in their family members and in a control cohort. The electrophysiological properties will be measured with the relatively new technique ECG-Imaging (ECGI). Also a National Dutch registry for patients with unexplained polymorphic VT and/or VF and their family members will be created. By combining the data from the registry and the results of ECGI, The investigators hope to identity risk markers for patients at higher risk for apparently idiopathic ventricular fibrillation, and use these for an adapted flow chart for the 'general'population of patients at risk for unexplained polymorphic VT and/or VF. The investigators aim to be able to identify patients before the first arrhythmic event, and aim for better treatment strategies in the future.

Conditions

Ventricular Fibrillation; Ventricular Arrythmia; Polymorphic Ventricular Tachycardia; Sudden Cardiac Death; Heart Arrest; Cardiovascular Diseases; Cardiac Arrhythmia; Genetic Disease; Idiopathic Ventricular Fibrillation; Cardiac Arrest

Keywords

idiopathic ventricular fibrillation; polymorphic ventricular tachycardia; body surface potential mapping; ECG Imaging

Outcome Measures

Primary Outcomes (2)

• ECG-Imaging outcome: epicardial potentials

  reconstructed epicardial potentials, represented in mV over time(s).

  3 years

• ECG-Imaging outcome: activation and repolarization maps

  Activation and repolarization maps. These are made by measuring acivation and repolarization times from the reconstructed potentials in miliseconds. Then local activation and recovery times are plotted on a CT-derived heart mesh. The entire activation and repolarization of the epicardium of the heart can be visualized this way.

  3 years

Secondary Outcomes (2)

• (Possible) Prognostic risk factors for recurrent ventricular arrhythmias

  3 years

• Recurrence of ventricular arrhythmias

  3 years

Study Arms (3)

Patients with unexplained polymorphic VT and/or VF

1. Unexplained polymorphic VT and/or VF patients. 2. Patients with VF and the DPP6 risk haplotype, reported by the AUMC team. 3. The Worm population of patients with a SCN5A founder mutation and other conspiring genetic variants at MUMC+

Diagnostic Test: ECG-Imaging

Family members

Family members of index patients of group(s) mentioned above

Diagnostic Test: ECG-Imaging

Control group

Control subjects with structurally normal hearts with an indication for a cardiac CT,

Diagnostic Test: ECG-Imaging

Interventions

ECG-Imaging DIAGNOSTIC_TEST

A body surface potential mapping and a cardiac + low dose CT-scan.

Control group; Family members; Patients with unexplained polymorphic VT and/or VF

Eligibility Criteria

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

Study Population

patients seen at the outpatient clinic at the department of cardiology or (cardio)genetics, patients admitted to the ward of cardiology or the intensive care unit.

You may qualify if:

• In order to be eligible to participate in this study, a subject must be ≥ 18 years old and meet one of the following criteria:
• Selected family members of these patients\*
• Control subjects with structurally normal hearts with a clinical indication for a cardiac CT scan.
• All 1st and 2nd degree family members being in contact with the cardiologist/treating physician as part of cascade screening will be contacted as described in chapter 11.2.2.
• Family members must be in adequate health to be able to travel to the hospital for research purposes.
• rd degree family members can also be contacted as described in chapter 11.2.2 if at least one of the following criteria is met:
• The family member has the same genetic mutation as index patient, or;
• The family member has demonstrated ventricular arrhythmias, or;
• The clinician has a very strong suspicion of ventricular arrhythmias in the family member.

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• A known strong reaction against electrode attachment or contrast agent.
• Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study.
• Pregnancy, nursing or planning to be pregnant.
• Subject has an estimated glomerular filtration rate (eGFR) of \<30mL/min/1.73m2
• , using the MDRD calculation
• Unability to give informed consent.
• Family members of patients with unexplained polymorphic VT/VF, who have severe cardiac abnormalities and/or disease not related to the symptoms or phenotype of the index patient, and which may have a negative influence on results of ECGI according to local investigators.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Dutch Heart Foundation: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• UMC Utrecht: collaborator

Study Sites (3)

Maastricht Universite Medical Centre

Maastricht, Nederland, Netherlands

Location

Amsterdam University medical Centre, location AMC

Amsterdam, Netherlands

Location

University Medical Centre Utrecht

Utrecht, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples from blood, if analysed upon clinical indication

MeSH Terms

Conditions

Ventricular Fibrillation; Death, Sudden, Cardiac; Heart Arrest; Cardiovascular Diseases; Arrhythmias, Cardiac; Genetic Diseases, Inborn; Paroxysmal ventricular fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death, Sudden; Death; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Paul Volders, MD, PhD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 24, 2019
• Study Start: April 10, 2019
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

NL (3)