- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01947543
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Withdrawn
Conditions
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
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Örebro, Sweden, 70185
- Department of Cardiology, Örebro University Hospital
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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 |
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Ventricular tachycardia
Patients with ventricular tachycardia of unknown origin treated with an ICD.
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Family members
Family members (parents, siblings and children) for patients with results showing mutations in the calmodulin genes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mutations in the calmodulin genes
Time Frame: 1 month.
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1 month.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol no: 2012-11
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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