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7 Tesla MRI Study in Patients With Statin Related Muscle Complaints

NCT04575090 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-10-31

Study results available
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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.

Conditions

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

Interventions

DRUG

Simvastatin

Simvastatin 40 mg daily.

Sponsors & Collaborators

  • Garg, Abhimanya, M.D.

    collaborator INDIV

  • Prishant Mishra

    collaborator UNKNOWN

  • Jimin Ren

    collaborator UNKNOWN

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-05
Primary Completion
2017-02-20
Completion
2021-06-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04575090 on ClinicalTrials.gov