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NCT01301235 Clinical Trial

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

Mitochondrial Disease Clinical Trial

Official title:
Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics of the Vastus Lateralis After Sub-maximal Exercise in Patients With Mitochondrial Myopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01301235
Other study ID # 2010P002441
Secondary ID
Status Completed
Phase N/A
First received February 18, 2011
Last updated April 27, 2012
Start date February 2011
Est. completion date April 2012

Study information
Verified date April 2012
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Partners Human Research Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date April 2012
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 -

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary PCr recovery after submaximal exercise by 31P-MRS 1 year No
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