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Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases

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.
 
ClinicalTrials.gov Identifier: NCT00221832
Recruitment Status : Unknown
Verified October 2003 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : January 13, 2010
Sponsor:
Information provided by:
Heidelberg University

Tracking Information
First Submitted Date September 14, 2005
First Posted Date September 22, 2005
Last Update Posted Date January 13, 2010
Study Start Date October 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases
Official Title Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases
Brief Summary The aim of this study is the identification of familial congenital arrhythmogenic disorders and their clinical follow-up.
Detailed Description

Molecular genetic screening in patients with:

  • supraventricular
  • ventricular arrhythmia
  • syncopes of unknown origin and/or suspicion of an arrhythmogenic origin
  • family members of patients with sudden cardiac death and aborted sudden cardiac death

Examination of patients includes routine testing like electrocardiogram (ECG), sequential ECGs, exercise testing, invasive electrophysiological stimulation, cardiac magnetic resonance imaging, intravenous drug challenge for identification/exclusion of eg Brugada syndrome. Examples are patients with Long QT Syndrome, Short QT Syndrome, Brugada Syndrome, familial atrial fibrillation, WPW-syndrome, arrhythmias due to familial hypertrophic cardiomyopathy or arrhythmogenic right ventricular dysplasia. Blood samples are taken for further molecular genetic screening.

Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
no biospecimens are to be retained.
Sampling Method Non-Probability Sample
Study Population Consecutive patient sampling with history of syncope, aborted SCD, familial sudden cardiac death, high suspicion of familial cardiac arrhythmias.
Condition
  • Long QT Syndrome
  • Hypertrophic Cardiomyopathy
  • Arrhythmogenic Right Ventricular Dysplasia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January¬†31,¬†2006)
300
Original Enrollment Not Provided
Estimated Study Completion Date December 2011
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Patients with a history of syncope, abnormal ECG and suspicion of an arrhythmogenic disease
  • Patients with long QT syndrome
  • Patients with short QT syndrome, shortened QT intervals, borderline shortened QT intervals
  • Patients with Brugada syndrome
  • Patients with hypertrophic cardiomyopathy
  • Patients with arrhythmogenic right ventricular dysplasia

Exclusion Criteria:

  • Inability to understand study protocol
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00221832
Other Study ID Numbers 0261.5
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof. C. Wolpert, I. Department of Medicine-Cardiology, University Hospital Mannheim, . Department of Medicine-Cardiology, University Hospital Mannheim
Study Sponsor Heidelberg University
Collaborators Not Provided
Investigators
Study Director: Martin Borggrefe, Prof., MD I. Department of Medicine-Cardiology
PRS Account Heidelberg University
Verification Date October 2003