Status:
TERMINATED
7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Muscle Cramp
Ache
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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. ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Inclusion
- • Adults, age \> 18 ys or \< 80 yrs. Patients reporting complaints of statin-associated muscle symptoms, aches, weakness, cramps, or stiffness in the legs.
- Exclusion Criteria
- Patient who drink large quantities of grapefruit juice (\> 1 quart daily).
- Patients on the following drugs for which the FDA has issued restrictions for using simvastatin 40 mg daily do to an increased risk of severe muscle injury such as itraconazole, posaconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV-1 protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, amlodipine, ranolazine, and verapamil.
- Patients with muscle-related pain that is not related to statin-use (e.g. muscle aches from strain or trauma) or remains unexplained.
- Any patients with underlying non-statin related muscle disorders.
- Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins.
- Conditions of severe acute vascular stress (acute coronary syndrome, ischemic stroke, or major vascular surgery) within prior 3 months.
- Any patients with a history of severe or life-threatening reactions to statins including rhabdomyolysis (defined as evidence of organ damage with CK \>10,000 IU/L), CK elevation \> 10 times the upper limit of normal, cognitive decline, transaminitis, or allergic reactions.
- History of fibromyalgia or rheumatologic disease with symptoms that may be confounded with statin-related muscle complaints.
- Patients unable to maintain their current activity level or planning to increase their activity level (e.g. new exercise regimen). Such changes may have acute effects on muscle metabolism.
- Pregnant or breast-feeding women. Statins are teratogenic, and the effects of high magnetic fields on a fetus are unknown.
- Women of reproductive age not on effective contraception. Adequate contraceptive measures include intrauterine device (IUD); bilateral tubal ligation; condom or diaphragm plus either contraceptive sponge, foam or jelly.
- Any person with implanted metal, because of MRS safety.
- Use of any active investigational drugs within 1 month or 5 half-lives, whichever is longer.
- History of antibodies to HMGCoA.
Exclusion
Key Trial Info
Start Date :
August 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04507373
Start Date
August 17 2018
End Date
December 20 2021
Last Update
February 14 2023
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390