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

NCT01481298 | Completed

• 1 other identifier: LVNC 2011
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Left Ventricular Non-compaction Cardiomyopathy; Left Ventricular Failure; Left Ventricular Hypertrophy

Study Arms (4)

LVNC

12 patients with left ventricular non-compaction cardiomyopathy

HCM

10 patients with hypertrophic cardiomyopathy

DCM

11 patients with dilatative cardiomyopathy

controls

24 healthy controls

Eligibility Criteria

• Age: 14 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Twelve patients (3 male, 27%) with proven LVNC, two with familial LVNC, were included into the study. The patients initially presented with symptoms of heart failure and were referred to the department of cardiology for further evaluation. All patients underwent echocardiography performed by experienced specialists and fulfilled the LVNC criteria of Jenni. CMR imaging was performed within 3 days after echocardiography. Exclusion criteria were co-existing cardiac anomalies and usual CMR contraindications such as implanted defibrillators/pacemakers. The investigators furthermore included 10 consecutive patients (4 male, 36%) with HCM and 11 consecutive patients (3 male, 27%) with DCM. The diagnosis of HCM and DCM was established according to current guidelines Patient parameters were compared to a control group of 25 healthy age matched volunteers (12 male, 48%) without history of cardiovascular disease and without clinical symptoms.

You may qualify if:

• left ventricular non-compaction cardiomyopathy
• dilatative cardiomyopathy
• hypertrophic cardiomyopathy or healty controls

You may not qualify if:

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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University of Leipzig - Heart Center

Leipzig, 04289, Germany

Location

MeSH Terms

Conditions

Heart Failure; Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: November 25, 2011
• First Posted: November 29, 2011
• Study Start: December 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 29, 2011

Record last verified: 2011-11

Locations

DE (1)