Clinical Trials Logo
  1. Home
  2. Weakness, Muscle
  3. NCT04507373

7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events

Weakness, Muscle Clinical Trial

Official title:
7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin

Clinical Trial Summary

Over 40 million Americans take statins to reduce their risk of atherosclerotic cardiovascular disease (ASCVD). Unfortunately, 10 to 20% stop taking them due to statin-associated muscle symptoms (e.g. pain, aches, weakness, cramps, or stiffness) (1, 2). The pathophysiology of these statin-associated muscle symptoms (SAMS) has remained elusive. Consequently, no objective diagnostic method exists, causing confusion for patient and providers since muscle symptoms can often be multifactorial.

Clinical Trial Description

The overall objectives of this project are to identify the underlying cause of SAMS and establish an in-vivo imaging technique to detect SAMS. The central hypothesis of this pro-posal is that statins directly inhibit mitochondrial function in SAMS patients. Our rationale is based on our own preliminary data indicating that simvastatin - the most common statin to cause SAMS - can directly inhibit oxidative phosphorylation (OXPHOS) in mice. Since such changes can be detected in vivo in humans utilizing 31P magnetic resonance spectroscopy (MRS) techniques, the investigators will use a state-of-the art 7 Tesla (7T) MRS instrument to study the so-leus muscles of SAMS patients. Additionally, the investigators will validate the MRS findings by doing func-tional studies in muscle biopsy specimens. The investigators propose double-blind randomized, placebo-controlled pilot study in 15 SAMS pa-tients and 15 controls. Study participants will be treated with simvastatin 40 mg daily or place-bo for 10 weeks. The investigators will perform 7T MRS of soleus muscles at randomization and either at first complaint of muscle symptoms or at the end of 10 weeks if no muscle symptoms occur, whichever occurs first. Quadriceps muscle biopsies will also be done immediately following the second MRS scan. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04507373
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Terminated
Phase Phase 4
Start date August 17, 2018
Completion date December 20, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT05071469 - Comparison of Two Different Treatment Methods N/A
Terminated NCT03735693 - Diagnosis of Muscular Weakness Syndrome After a Stay in Intensive Care : Measurement by Ultrasound
Withdrawn NCT04844307 - Comparing Inpatient COVID-19 Outcomes in 2 Different PT Dosing Groups N/A
Completed NCT04757415 - Gluteal Activation With or Without Traction Straight Leg Raise Technique N/A
Completed NCT05072652 - Short Term Immobilization of the Lower Limb N/A
Completed NCT05087862 - Periarticular Infiltration of Local Anesthetics Versus Pericapsular Nerve Group Block for Total Hip Replacement N/A
Recruiting NCT05815017 - YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility N/A
Recruiting NCT05877846 - Precision Medicine and Physical Function N/A
Recruiting NCT05725928 - Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients N/A
Terminated NCT04309227 - Comparison of Training Load With/Out Blood Flow Restriction Training in Rheumatoid Populations N/A
Recruiting NCT05941962 - Use of Hand-held Dynamometry to Obtain Objective Measures of Lower Extremity Force Production With Chronic Stroke
Active, not recruiting NCT03619772 - EMG Training for Altering Activation Patterns After Stroke N/A
Completed NCT03817086 - Physical and Mental Practice for Bimanual Coordination Rehabilitation N/A
Completed NCT05670327 - Diaphragmatic Ultrasound and Weaning After Lung Transplant.
Not yet recruiting NCT06441422 - Blood Flow Restriction Training for People With Disabilities N/A
Active, not recruiting NCT04516642 - Swiss Frailty Network and Repository
Recruiting NCT05967611 - Hip Abductor Function During Trendelenburg Test
Completed NCT03850106 - Effects of INDUS810 on Body Composition, Muscular Performance, and Training Adaptations N/A
Completed NCT04862481 - Physical Function of Older Citizens During Municipality-based Rehabilitation
Completed NCT04864093 - Muscular Ultrasound and Production of ICUAW