Investigation of Cognitive Function Before and After Indu... | NCT00176176

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

NCT00176176

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Oct 12, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Ventricular Fibrillation
Ventricular Tachycardia

Interventions

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2004

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2006

Last Update Posted Date

Oct 12, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
EEG	Device

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christian Wolpert, PD, MD	Contact	+49-621-383-2206		christian.wolpert@med.ma. uni-heidelberg.de

Overall Officials

Name	Affiliation	Role
Martin Borggrefe, Prof., MD	I.Medizinische Klinik, Universitätsklinikum Mannheim	Study Director
M Hennerici, Prof., MD	Neurologische Klinik Universitätsklinikum Mannheim	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fakultät für Klinische Medizin Mannheim Universitätsklinikum Mannheim der Ruprecht-Karls-Universität Heidelberg	Recruiting	Mannheim		68167	Germany

Condition Browse Module

MeSH Terms

ID	Term
D014693	Ventricular Fibrillation
D017180	Tachycardia, Ventricular

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004569	Electroencephalography

Ancestor Terms

ID	Term
D003943	Diagnostic Techniques, Neurological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004568	Electrodiagnosis

Browse Leaves

Not provided

Browse Branches

Not provided