7 Tesla MRI Study in Patients With Statin Related Muscle Complaints

NCT04575090 | Completed Results DMC

• 1 other identifier: STU 012016-017
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Pre- and Post-phosphocreatine Relaxation Time

  Measure differences in pre- and post-phosphocreatine relaxation time in SAMS (Statin Associated Muscle Symptoms) patients on simvastatin compared to placebo.

  Baseline, 10 Weeks

Study Arms (3)

Arm 1 (Observational Arm)

NO INTERVENTION

Patients in substudy 1 will be identified by the PI from the clinic as individuals who are currently experiencing statin related muscle complaints or who have had severe reactions to statins in the past. There is going to be only one visit which will last for apprximately 3.5 hrs. Subjects will have height, weight and vitals measured. They will be asked pain and and demographic questionnaire. They will have their blood draw and will undergo MRS.

Arm 2 (Interventional Experimental Arm)

EXPERIMENTAL

Subjects with statin related muscle complaints were enrolled in this arm and will have 3 visits. First visit is screening visit which will last for about 2 hrs and the next 2 visits will last for about 3.5 hrs. The screening visit will occur 2 weeks prior to visit 1. Subjects will have height, weight and vitals measured. They will be asked pain and and demographic questionnaire. They will have their blood draw and will undergo MRS. Some volunteers who do/do not regularly exercise or are/are not active in sports may be asked to exercise prior to the MRS. This exercise may be in the form of hand grasps, toe-raises, bicycling on a stationary bike or walking on a treadmill. Exercise will be limited to up to one hour, during which time the subject's vital signs and blood oxygenation will be monitored. During the scan, the subject's heart rate and respiratory rate may be monitored

Drug: Simvastatin

Arm 3 (Interventional Control Arm)

EXPERIMENTAL

Subjects with no statin related muscle complaints were enrolled in this arm and will have 3 visits. First visit is screening visit which will last for about 2 hrs and the next 2 visits will last for about 3.5 hrs. The screening visit will occur 2 weeks prior to visit 1. Subjects will have height, weight and vitals measured. They will be asked pain and and demographic questionnaire. They will have their blood draw and will undergo MRS. Some volunteers who do/do not regularly exercise or are/are not active in sports may be asked to exercise prior to the MRS. This exercise may be in the form of hand grasps, toe-raises, bicycling on a stationary bike or walking on a treadmill. Exercise will be limited to up to one hour, during which time the subject's vital signs and blood oxygenation will be monitored. During the scan, the subject's heart rate and respiratory rate may be monitored

Drug: Simvastatin

Interventions

Simvastatin DRUG

Simvastatin 40 mg daily.

Arm 2 (Interventional Experimental Arm); Arm 3 (Interventional Control Arm)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age \>18 yrs or \<80 yrs Patients reporting complaints of statin-associated muscle symptoms, aches, weakness, cramps, or stiffness of legs.

You may not qualify if:

• Patients who drink large quantities of grapefruit juice (\>1 quart daily)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Garg, Abhimanya, M.D.: collaborator
• Prishant Mishra: collaborator
• Jimin Ren: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Myalgia; Muscle Weakness; Muscle Cramp

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Pathologic Processes

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

There was an error / typo in the explanation that was provided at the time of the previous submission within this section. Hence to clarify and confirm - Arm 1 is an observational study. No intervention is involved. No data was collected for arm 1.

Results Point of Contact

• Title: Zahid Ahmand, MD
• Organization: UTSouthwestern Medical Center

zahid.ahmad@utsouthwestern.edu

214-648-2377

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: October 5, 2020
• Study Start: March 5, 2016
• Primary Completion: February 20, 2017
• Study Completion: June 23, 2021
• Last Updated: October 31, 2022
• Results First Posted: October 31, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)