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N/A N=8 Diagnostic

7 Tesla MRI Study in Patients With Statin Related Muscle Complaints

Statin-related Muscle Pain · Muscle Aches · Muscle Weakness · Muscle Cramp · Muscle Stiffness

Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Change in Pre- and Post-phosphocreatine Relaxation Time — 5.58; 5.083 milliseconds

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Simvastatin (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Texas Southwestern Medical Center
Primary completion
Feb 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Pre- and Post-phosphocreatine Relaxation Time
5.58; 5.083

Summary

Roughly 5-10% of statin-treated patients report muscle pain, aches, weakness, cramps, stiffness, or "heaviness" - typically occurring symmetrically in the legs. For healthcare providers, the major diagnostic challenge is to unambiguously link these symptoms to statin use, especially since some patients can have normal serum creatine kinase (CK) levels despite demonstrable weakness and muscle biopsy proven statin-induced myopathy . No well accepted, standardized, or Food and Drug Administration (FDA)-endorsed diagnostic method exists for statin-induced muscle injury. This lack of an objective diagnostic methodology blocks vertical advancement of the field. The successful completion of this project will develop in vivo techniques that will provide insight into how statins affect muscle metabolism and help establish a methodology to objectively diagnose muscle injury due to statins. The development of an MRS technique will allow for in-vivo analyses and the data accumulated here will serve as preliminary data for futher extramural funding of studies with much larger sample sizes. Ultimately, this focus of research will lead to improved diagnosis and treatment of patients with statin-related muscle complaints, which is central to obtaining the cardiovascular risk reduction from lipid-lowering drugs.

Eligibility Criteria

Inclusion Criteria

Adults age >18 yrs or 1 quart daily)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04575090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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