Calmodulin Gene Mutations in Patients With Ventricular Arrhythmia of Unknown Origin - A Screening Study

April 10, 2018 updated by: Ole Frobert, MD, PhD, Region Örebro County
The aim of this study is to screen a well characterized patient population with ventricular tachycardia of unknown origin and treated with an implantable cardioverter-defibrillator (ICD) for mutations in the calmodulin genes.

Study Overview

Status

Withdrawn

Detailed Description

Patients with ventricular tachycardia of unknown origin and treated with an implantable cardioverter-defibrillator (ICD) will be asked to participate in the study. For patients with results showing mutations in the calmodulin genes, family members (parents, siblings and children) will also be asked to participate in the study. For under age patients and relatives who agree to participate, informed consent will also be taken from their custodian.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Örebro, Sweden, 70185
        • Department of Cardiology, Örebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with ventricular tachycardia of unknown origin and treated with an ICD

Description

Inclusion Criteria:

  • Patients with ventricular tachycardia of unknown origin that have been treated with an ICD
  • Signed and dated informed consent

Exclusion Criteria:

- Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Ventricular tachycardia
Patients with ventricular tachycardia of unknown origin treated with an ICD.
Family members
Family members (parents, siblings and children) for patients with results showing mutations in the calmodulin genes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mutations in the calmodulin genes
Time Frame: 1 month.
1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ole Fröbert, MD, Ph.D., Department of Cardiology, Örebro University Hospital, Örebro, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Actual)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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