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

December 9, 2015 updated by: University of Zurich

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

Study Type

Observational

Enrollment (Actual)

39

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

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

30 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

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
IVNC
differential diagnosis to IVNC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Felix Tanner, Prof. MD, University Hospital Zurich, Division of Cardiology

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

October 1, 2011

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

October 27, 2011

First Submitted That Met QC Criteria

November 9, 2011

First Posted (ESTIMATE)

November 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2015

Last Update Submitted That Met QC Criteria

December 9, 2015

Last Verified

December 1, 2015

More Information

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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