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Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics in Patients With Mitochondrial Myopathy

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01301235
Collaborator
(none)
8
Enrollment
1
Location
14
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a developmental protocol to determine the MRI based 31P-MRS changes seen in subjects with mitochondrial myopathy using our dynamic exercise protocol and to identify the ideal variable(s) to represent mitochondrial function.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    8 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics of the Vastus Lateralis After Sub-maximal Exercise in Patients With Mitochondrial Myopathy
    Study Start Date :
    Feb 1, 2011
    Actual Primary Completion Date :
    Nov 1, 2011
    Actual Study Completion Date :
    Apr 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Subjects with mitochondrial disease

    Outcome Measures

    Primary Outcome Measures

    1. PCr recovery after submaximal exercise by 31P-MRS [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Men and women ≥ age 18 years old with primary mitochondrial myopathy

    2. Known alteration in electron transport chain activity (<25 % activity of ETC) or known mutations in mitochondrial gene.

    Exclusion Criteria:

    Failure based on standard clinical MRI Screening form - the form is intended to establish the safety of subjects participating in the MRI scan without divulging any confidentiality information -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amy Fleischman, MD, Clinical Investigator, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT01301235
    Other Study ID Numbers:
    • 2010P002441
    First Posted:
    Feb 23, 2011
    Last Update Posted:
    Apr 30, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by Amy Fleischman, MD, Clinical Investigator, Massachusetts General Hospital
    Mitochondria
    Additional relevant MeSH terms:
    Mitochondrial Myopathies
    Mitochondrial Diseases

    Study Results

    No Results Posted as of Apr 30, 2012