Ventricular TachycardiaNCT01947543
Calmodulin Gene Mutations in Patients With Ventricular Arrhythmia of Unknown Origin - A Screening Study
An observational study of Ventricular Tachycardia, run by Region Örebro County at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ventricular Tachycardia
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2017to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with ventricular tachycardia of unknown origin and treated with an ICD
Who may be able to join
- Patients with ventricular tachycardia of unknown origin that have been treated with an ICD
- Signed and dated informed consent
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Cardiology, Örebro University Hospital
Örebro, 70185
About this study
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.
Read the 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.
- Conditions
- Ventricular Tachycardia
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Mutations in the calmodulin genes
Measured: 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJan 2017
- Primary completionApr 2018 (estimated)
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole Frobert, MD, PhD, Region Örebro County
- Investigators
- Ole Fröbert, MD, Ph.D., Principal investigator, Department of Cardiology, Örebro University Hospital, Örebro, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947543
- Sponsor's protocol ID
- Protocol no: 2012-11
- Status last verified
- Apr 2018
- First submitted
- 27 Aug 2013
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calmodulin Gene Mutations in Patients With Ventricular Arrhythmia of Unknown Origin - A Screening Study
- ClinicalTrials.gov ID
- NCT01947543
- Acronym / sponsor ID
- Protocol no: 2012-11
- Conditions
- Ventricular Tachycardia
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ventricular tachycardia of unknown origin and treated with an ICD
Key inclusion criteria (2 listed)
- Patients with ventricular tachycardia of unknown origin that have been treated with an ICD
- Signed and dated informed consent
Key exclusion criteria (1 listed)
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mutations in the calmodulin genes
Time frame: 1 month.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Fröbert, MD, Ph.D. principal investigator
Department of Cardiology, Örebro University Hospital, Örebro, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mutations in the calmodulin genes (time frame: 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.