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NCT00176176 Clinical Trial

Investigation of Cognitive Function Before and After Induced Ventricular Fibrillation in Electrophysiological (EP) Study

Ventricular Tachycardia Clinical Trial

Official title:
Change of EEG Activity and Cerebral Circulation During Induced Ventricular Fibrillation and Investigation of Cognitive Function Before and After Induced Ventricular Fibrillation in EP Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00176176
Other study ID # 235/04
Secondary ID
Status Recruiting
Phase N/A
First received September 13, 2005
Last updated October 11, 2006

Study information
Verified date November 2004
Source Heidelberg University
Contact Christian Wolpert, PD, MD
Phone +49-621-383-2206
Email christian.wolpert@med.ma. uni-heidelberg.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

In this study, changes in electroencephalogram (EEG) and the hemodynamic state during ventricular fibrillation or induced ventricular tachycardia are investigated.

Description:

Patients with a high risk of malignant tachyarrhythmia are routinely investigated by programmed electrophysiological study (EPS). To investigate the hemodynamic effects of ventricular arrhythmia to cerebral circulation an EEG and transcranial ultrasound are conducted simultaneously during the EPS. Before and after the EPS a neuropsychological test and an investigation of a specific blood sample (Neuron Specific Enolase, NSE) is done.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18 years

- Positive agreement

- EPS for primary and secondary prophylaxis of a malignant ventricular tachyarrhythmia:

- primary prophylaxis: Brugada syndrome, long QT syndrome, cardiomyopathy, short QT syndrome

- secondary prophylaxis: Multicenter Automatic Defibrillator Implantation Trial (MADIT) criteria, syncope, documented ventricular tachycardia

Exclusion Criteria:

- Severe neurological deficit

- Cardiopulmonary resuscitation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• EEG

Locations
Country Name City State
Germany Fakultät für Klinische Medizin Mannheim Universitätsklinikum Mannheim der Ruprecht-Karls-Universität Heidelberg Mannheim

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

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