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

Left Ventricular Noncompaction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470014
• Other study ID #: KEK 2011-0099
• Status: Completed
• Phase: N/A
• First received: October 27, 2011
• Last updated: December 9, 2015
• Start date: October 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Isolated Noncompaction of the Ventricular Myocardium
• Left Ventricular Noncompaction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland,