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

NCT01470014 | Completed

• 1 other identifier: KEK 2011-0099
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Ventricular Noncompaction; Isolated Noncompaction of the Ventricular Myocardium

Keywords

isolated left ventricular non-compaction; cardiac computed tomography; cardiac magnet resonance imaging; echocardiography

Study Arms (2)

IVNC

differential diagnosis to IVNC

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

MeSH Terms

Conditions

Isolated Noncompaction of the Ventricular Myocardium

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Endocardial Fibroelastosis; Cardiomyopathies; Heart Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked; Genetic Diseases, Inborn

Study Officials

• Felix Tanner, Prof. MD

  University Hospital Zurich, Division of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 10, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

CH (1)