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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2004 by Heidelberg University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176176
First Posted: September 15, 2005
Last Update Posted: October 12, 2006
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.
Information provided by:
Heidelberg University
  Purpose
In this study, changes in electroencephalogram (EEG) and the hemodynamic state during ventricular fibrillation or induced ventricular tachycardia are investigated.

Condition Intervention
Ventricular Fibrillation Ventricular Tachycardia Device: EEG

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Estimated Enrollment: 30
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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00176176


Contacts
Contact: Christian Wolpert, PD, MD +49-621-383-2206 christian.wolpert@med.ma. uni-heidelberg.de

Locations
Germany
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    christian.wolpert@med.ma. uni-heidelberg.de   
Principal Investigator: Constanze M Echternach, MD         
Sponsors and Collaborators
Heidelberg University
Investigators
Study Director: Martin Borggrefe, Prof., MD I. Medizinische Klinik Universitätsklinikum Mannheim
Study Director: M Hennerici, Prof., MD Neurologische Klinik Universitätsklinikum Mannheim
  More Information

ClinicalTrials.gov Identifier: NCT00176176     History of Changes
Other Study ID Numbers: 235/04
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: October 12, 2006
Last Verified: November 2004

Keywords provided by Heidelberg University:
cerebral circulation

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes