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

Primary Purpose

Ventricular Fibrillation, Ventricular Tachycardia

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

EEG

About this trial

This is an interventional diagnostic trial for Ventricular Fibrillation focused on measuring cerebral circulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

Fakultät für Klinische Medizin Mannheim Universitätsklinikum Mannheim der Ruprecht-Karls-Universität HeidelbergRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00176176

First Posted

September 13, 2005

Last Updated

October 11, 2006

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT00176176

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2004

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventricular Fibrillation, Ventricular Tachycardia

Keywords

cerebral circulation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

EEG

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian Wolpert, PD, MD

Phone

+49-621-383-2206

christian.wolpert@med.ma. uni-heidelberg.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Borggrefe, Prof., MD

Organizational Affiliation

I.Medizinische Klinik, Universitätsklinikum Mannheim

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

M Hennerici, Prof., MD

Organizational Affiliation

Neurologische Klinik Universitätsklinikum Mannheim

Official's Role

Study Director

Facility Information:

Facility Name

Fakultät für Klinische Medizin Mannheim Universitätsklinikum Mannheim der Ruprecht-Karls-Universität Heidelberg

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christian Wolpert, PD, MD

Phone

+49-621-383-2206

christian.wolpert@med.ma. uni-heidelberg.de

First Name & Middle Initial & Last Name & Degree

Constanze M Echternach, MD

12. IPD Sharing Statement

Learn more about this trial

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

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