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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00176176
Recruitment Status : Unknown
Verified November 2004 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : October 12, 2006
Information provided by:
Heidelberg University

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

Condition or disease Intervention/treatment Phase
Ventricular Fibrillation Ventricular Tachycardia Device: EEG Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00176176

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Contact: Christian Wolpert, PD, MD +49-621-383-2206

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Fakultät für Klinische Medizin Mannheim Universitätsklinikum Mannheim der Ruprecht-Karls-Universität Heidelberg Recruiting
Mannheim, Germany, 68167
Contact: Christian Wolpert, PD, MD    +49-621-383-2206   
Principal Investigator: Constanze M Echternach, MD         
Sponsors and Collaborators
Heidelberg University
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Study Director: Martin Borggrefe, Prof., MD I. Medizinische Klinik Universitätsklinikum Mannheim
Study Director: M Hennerici, Prof., MD Neurologische Klinik Universitätsklinikum Mannheim
Layout table for additonal information Identifier: NCT00176176    
Other Study ID Numbers: 235/04
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: October 12, 2006
Last Verified: November 2004
Keywords provided by Heidelberg University:
cerebral circulation
Additional relevant MeSH terms:
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Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes