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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matthias Grothoff, M.D., University of Leipzig
ClinicalTrials.gov Identifier:
NCT01481298
First received: November 25, 2011
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Value of Different Myocardial Parameters to Differentiate Left Ventricular Noncompaction Cardiomyopathy From Other Cardiomyopathies and Healthy Controls by Cardiac Magnetic Resonance

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Enrollment: 57
Study Start Date: December 2004
Study Completion Date: October 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   14 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01481298

Locations
Germany
University of Leipzig - Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
  More Information

No publications provided

Responsible Party: Matthias Grothoff, M.D., Dr. med., University of Leipzig
ClinicalTrials.gov Identifier: NCT01481298     History of Changes
Other Study ID Numbers: LVNC 2011
Study First Received: November 25, 2011
Last Updated: November 28, 2011
Health Authority: Federal Institute for Drugs and Medical Devices Germany:

Additional relevant MeSH terms:
Hypertrophy
Heart Failure
Hypertrophy, Left Ventricular
Cardiomyopathies
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Cardiomegaly

ClinicalTrials.gov processed this record on July 26, 2014