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NCT04575090 · ClinicalTrials.gov registry record · NA
7 Tesla MRI Study in Patients With Statin Related Muscle Complaints
A NA study of Muscle Weakness and Statin-related Muscle Pain, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT04575090: Completed NA study of Muscle Weakness and Statin-related Muscle Pain, sponsored by University of Texas Southwestern Medical Center.
NCT04575090 is a NA study of Muscle Weakness and Statin-related Muscle Pain that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 8 participants, below the 75-participant average among 25 other Muscle Weakness trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04575090, a NA study of Muscle Weakness and Statin-related Muscle Pain, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Measure differences in pre- and post-phosphocreatine relaxation time in SAMS (Statin Associated Muscle Symptoms) patients on simvastatin compared to placebo.
Conditions Studied
Interventions
- DRUG Simvastatin
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2016-03-05 |
| Est. Completion | 2021-06-23 |
| Phase | NA |
What the finished NCT04575090 record still lists
NCT04575090 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 75-participant average among 25 other Muscle Weakness trials with a reported enrollment target (89% lower).
The record links to 5 conditions, with Muscle Weakness appearing as the primary indexed condition, and to 1 intervention - of which Simvastatin is the first listed.
NCT04575090 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04575090 about?
NCT04575090 is a clinical study titled "7 Tesla MRI Study in Patients With Statin Related Muscle Complaints". 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 patie...
What is the current status of trial NCT04575090?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2016-03-05. Estimated completion is 2021-06-23.
What conditions does trial NCT04575090 study?
This clinical trial studies the following conditions: Muscle Weakness, Statin-related Muscle Pain, Muscle Aches, Muscle Cramp, Muscle Stiffness.
What interventions are being tested in trial NCT04575090?
The interventions under investigation include: Simvastatin (DRUG).
Who is sponsoring clinical trial NCT04575090?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04575090 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04575090's enrollment target sits among peer trials
8 26th of 25 the lowest of 25 other Muscle Weakness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Muscle Weakness trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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