Value of Cardiac Magnetic Resonance (CMR) Derived Parameters for Diagnosing Left Ventricular Non-compaction Cardiomyopathy

Left Ventricular Hypertrophy Clinical Trial

Official title:

Value of Different Myocardial Parameters to Differentiate Left Ventricular Noncompaction Cardiomyopathy From Other Cardiomyopathies and Healthy Controls by Cardiac Magnetic Resonance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481298
• Other study ID #: LVNC 2011
• Status: Completed
• Phase: N/A
• First received: November 25, 2011
• Last updated: November 28, 2011
• Start date: December 2004
• Est. completion date: October 2008

Study information

• Verified date: November 2011
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Federal Institute for Drugs and Medical Devices Germany:
• Study type: Observational

Clinical Trial Summary

Left ventricular non-compaction (LVNC) is a rare cardiomyopathy characterized by numerous excessively prominent left ventricular (LV) trabeculation and deep intertrabecular recesses communicating with the ventricular cavity and severely altering myocardial structure. Although most authors assume a developmental arrest in embryogenesis as the underlying pathology, the mechanisms of LVNC are not fully understood yet. Several gene mutations have been identified to be linked with LVNC and an autosomal dominant inheritance pattern is frequent To date the most commonly used imaging tool for diagnosing LVNC is echocardiography applying the criteria established by Jenni and coauthors However, qualitative parameters to differentiate normal compaction of the myocardium in healthy subjects from LVNC or from other cardiomyopathies like dilative cardiomyopathy (DCM) or hypertrophic cardiomyopathy (HCM) may fail due to highly variable LV trabeculation. Therefore, absolute quantification should be performed. Cardiac magnetic resonance (CMR) has been reported as a promising imaging modality to characterize patients with LVNC as it provides both a high spatial resolution and a good contrast between trabeculation and blood pool Jacquier et al. recently described a value of trabeculated LV myocardial mass above 20% of the global mass of the LV to be highly sensitive and specific for LVNC However, in their approach, a substantial degree of the LV cavity was included into calculated trabecular LV mass and led to systemic overestimation of the latter. Furthermore, the role and prognostic value of myocardial scarring as assessed by delayed enhancement (DE) CMR was not evaluated.

The aim of the retrospective study was to establish revised and extended CMR criteria to distinguish LVNC from DCM, HCM and a group of healthy controls and to improve the assessment of trabeculated mass by excluding intertrabecular blood pool.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 64 Years

Eligibility

Inclusion Criteria:

• left ventricular non-compaction cardiomyopathy

• dilatative cardiomyopathy

• hypertrophic cardiomyopathy or healty controls

Exclusion Criteria:

• contraindications for magnetic resonance imaging like pacemakers or other metallic implants

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Failure
• Left Ventricular Hypertrophy
• Left Ventricular Non-compaction Cardiomyopathy

Locations

Country	Name	City	State
Germany	University of Leipzig - Heart Center	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany,