- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01470014
Cardiac Computed Tomography: Characteristics of Isolated Left Ventricular Non-compaction
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 Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zurich, Switzerland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- 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
Exclusion criteria: Contraindication for cardiac CT
- 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)
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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IVNC
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differential diagnosis to IVNC
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Felix Tanner, Prof. MD, University Hospital Zurich, Division of Cardiology
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK 2011-0099
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.
Clinical Trials on Left Ventricular Noncompaction
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Lawson Health Research InstituteRecruiting
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University Hospital HeidelbergCharite University, Berlin, Germany; Goethe University; University Medicine Greifswald and other collaboratorsRecruitingAmyloidosis | HCM - Hypertrophic Cardiomyopathy | Arrhythmogenic Right Ventricular Cardiomyopathy | Inflammatory Cardiomyopathy | DCM - Dilated Cardiomyopathy | Non-ischemic Cardiomyopathy | HOCM - Hypertrophic Obstructive Cardiomyopathy | Left Ventricular Noncompaction CardiomyopathyGermany
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University of LeipzigCompletedLeft Ventricular Hypertrophy | Left Ventricular Failure | Left Ventricular Non-compaction CardiomyopathyGermany
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Lawson Health Research InstituteMedtronicTerminatedHeart Failure, Left Ventricular DysfunctionCanada
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AstraZenecaCompletedLeft Ventricle FunctionSweden
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Assistance Publique Hopitaux De MarseilleCompletedLeft Ventricular Non CompactionFrance
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Berlin Heals GmbHRecruitingSystolic Left Ventricular DysfunctionSerbia, Bosnia and Herzegovina
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Berlin Heals GmbHRecruitingSystolic Left Ventricular DysfunctionSwitzerland, Croatia, Germany, Spain, Serbia, Bosnia and Herzegovina, Bulgaria, Greece, North Macedonia, Poland, Czechia
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M.D. Anderson Cancer CenterCompletedHeart Failure | Cancer Treatment Induced Left Ventricular DysfunctionUnited States
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Berlin Heart, IncUnknownSevere Isolated Left Ventricular Dysfunction | Severe Biventricular Dysfunction