Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiac Computed Tomography: Characteristics of Isolated Left Ventricular Non-compaction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01470014
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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). 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.


Condition or disease
Left Ventricular Noncompaction Isolated Noncompaction of the Ventricular Myocardium

Layout table for study information
Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Group/Cohort
IVNC
differential diagnosis to IVNC




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470014


Locations
Layout table for location information
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Layout table for investigator information
Principal Investigator: Felix Tanner, Prof. MD University Hospital Zurich, Division of Cardiology
Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01470014    
Other Study ID Numbers: KEK 2011-0099
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015
Keywords provided by University of Zurich:
isolated left ventricular non-compaction
cardiac computed tomography
cardiac magnet resonance imaging
echocardiography
Additional relevant MeSH terms:
Layout table for MeSH terms
Isolated Noncompaction of the Ventricular Myocardium
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Endocardial Fibroelastosis
Cardiomyopathies
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, X-Linked
Genetic Diseases, Inborn