Left Ventricular NoncompactionNCT01470014
Cardiac Computed Tomography: Characteristics of Isolated Left Ventricular Non-compaction
An observational study of Left Ventricular Noncompaction and Isolated Noncompaction of the Ventricular Myocardium, run by University of Zurich at 1 site in Switzerland.
Trial summary
The diagnostic criteria for isolated left ventricular non-compaction cardiomyopathy (IVNC) have been well established for echocardiography and cardiac magnetic resonance, such validation is lacking for computed tomography (CT). Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Left Ventricular Noncompaction, Isolated Noncompaction of the Ventricular Myocardium
- How many people
- 39 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2011to Dec 2014
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the Department of Cardiology and Cardiac Imaging Division. They will be asked if they want to participate in this study.
Who may be able to join
- Established diagnosis of IVNC or differential diagnosis
- Age: Men > 30 years, women > 50 years without menstruation for at least 2 month.
- Written informed consent to participate
Who cannot join
- Renal insufficiency (GFR < 60ml/min)
- Known allergy to iodinated contrast agent
- Known Hyperthyroidism
- Non-sinus rhythm
- Known premature ventricular or supraventricular beats
- Hypotension (systolic blood pressure < 100mmHg)
Show all 13Show fewer
- Contraindication for CMR
- Implanted cardiac pacemaker or defibrillator
- Other implanted medical devices (e.g. implantable cardioverter-defibrillator)
- Claustrophobia
- Known premature ventricular or supraventricular beats
- Pregnancy
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
The diagnostic criteria for isolated left ventricular non-compaction cardiomyopathy (IVNC) have been well established for echocardiography and cardiac magnetic resonance, such validation is lacking for computed tomography (CT). Such criteria are of great clinical relevance as a growing number of patients undergo a cardiac CT scan in daily clinical routine.
The investigators aim to test the diagnostic accuracy of cardiac CT in distinguishing IVNC from lesser degrees of trabecular layering seen in potential differential diagnoses such as cardiomyopathies and left ventricular hypertrophy or dilation.
The investigators hypothesize that echocardiographic diagnosed pathological trabeculation can be distinguished by determining the ratio of non-compacted to compacted myocardium on cardiac CT.
- Keywords
- isolated left ventricular non-compaction, cardiac computed tomography, cardiac magnet resonance imaging, echocardiography
- Medical subject headings
- Isolated Noncompaction of the Ventricular Myocardium
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 |
|---|---|---|
| IVNC | Not described | |
| differential diagnosis to IVNC | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular NoncompactionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felix Tanner, Prof. MD, Principal investigator, University Hospital Zurich, Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470014
- Sponsor's protocol ID
- KEK 2011-0099
- Status last verified
- Dec 2015
- First submitted
- 27 Oct 2011
- Last updated
- 10 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Computed Tomography: Characteristics of Isolated Left Ventricular Non-compaction
- ClinicalTrials.gov ID
- NCT01470014
- Acronym / sponsor ID
- KEK 2011-0099
- Keywords
- isolated left ventricular non-compaction, cardiac computed tomography, cardiac magnet resonance imaging, echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Nov 2011 (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 diagnostic criteria for isolated left ventricular non-compaction cardiomyopathy (IVNC) have been well established for echocardiography and cardiac magnetic resonance, such validation is lacking for computed tomography (CT). Such criteria are of great clinical relevance as a growing number of patients undergo a cardiac CT scan in daily clinical routine.
The investigators aim to test the diagnostic accuracy of cardiac CT in distinguishing IVNC from lesser degrees of trabecular layering seen in potential differential diagnoses such as cardiomyopathies and left ventricular hypertrophy or dilation.
The investigators hypothesize that echocardiographic diagnosed pathological trabeculation can be distinguished by determining the ratio of non-compacted to compacted myocardium on cardiac CT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVNC | – | – |
| differential diagnosis to IVNC | – | – |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the Department of Cardiology and Cardiac Imaging Division. They will be asked if they want to participate in this study.
Key inclusion criteria (3 listed)
- Established diagnosis of IVNC or differential diagnosis
- Age: Men > 30 years, women > 50 years without menstruation for at least 2 month.
- Written informed consent to participate
Key exclusion criteria (13 listed)
- Renal insufficiency (GFR < 60ml/min)
- Known allergy to iodinated contrast agent
- Known Hyperthyroidism
- Non-sinus rhythm
- Known premature ventricular or supraventricular beats
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
Related trials for Left Ventricular Noncompaction
RecruitingObservational study
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
RecruitingObservational study
DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies
Non-ischemic Cardiomyopathy, DCM - Dilated Cardiomyopathy
RecruitingObservational study
Predictors of Risk in Left Ventricular Non-Compaction
Left Ventricular Noncompaction
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.
Felix Tanner, Prof. MD principal investigator
University Hospital Zurich, Division of Cardiology
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 Left Ventricular Noncompaction and Isolated Noncompaction of the Ventricular Myocardium, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 10 Dec 2015. 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 Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 10 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.