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

Sponsor
University of Leipzig (Other)
Overall Status
Completed
CT.gov ID
NCT01481298
Collaborator
(none)
57
Enrollment
1
Location
46
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    57 participants
    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
    Study Start Date :
    Dec 1, 2004
    Actual Primary Completion Date :
    Jul 1, 2008
    Actual Study Completion Date :
    Oct 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      14 Years to 64 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 University of Leipzig - Heart Center Leipzig Germany 04289

      Sponsors and Collaborators

      • University of Leipzig

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Matthias Grothoff, M.D., Dr. med., University of Leipzig
      ClinicalTrials.gov Identifier:
      NCT01481298
      Other Study ID Numbers:
      • LVNC 2011
      First Posted:
      Nov 29, 2011
      Last Update Posted:
      Nov 29, 2011
      Last Verified:
      Nov 1, 2011
      Additional relevant MeSH terms:
      Cardiomyopathies
      Hypertrophy, Left Ventricular
      Hypertrophy

      Study Results

      No Results Posted as of Nov 29, 2011