Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics in Patients With Mitochondrial Myopathy
This study has been completed.
Information provided by (Responsible Party):
Amy Fleischman, MD, Massachusetts General Hospital
First received: February 18, 2011
Last updated: April 27, 2012
Last verified: April 2012
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.
||Observational Model: Case-Only
Time Perspective: Cross-Sectional
||Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics of the Vastus Lateralis After Sub-maximal Exercise in Patients With Mitochondrial Myopathy
Primary Outcome Measures:
- PCr recovery after submaximal exercise by 31P-MRS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2011 (Final data collection date for primary outcome measure)
Subjects with mitochondrial disease
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Adults with mitochondrial disease
- Men and women ≥ age 18 years old with primary mitochondrial myopathy
- Known alteration in electron transport chain activity (<25 % activity of ETC) or known mutations in mitochondrial gene.
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 -
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01301235
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
Massachusetts General Hospital
No publications provided
||Amy Fleischman, MD, Clinical Investigator, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 18, 2011
||April 27, 2012
||United States: Partners Human Research Committee
Keywords provided by Massachusetts General Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 30, 2015
Nervous System Diseases