Could a simple blood test predict statin muscle pain?
NCT ID NCT07511686
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed observational study from Latvia looked at whether statin-related muscle symptoms are linked to problems in fat metabolism in muscle cells. Researchers measured acylcarnitine levels in blood and muscle samples from 38 adults, comparing those with statin-related muscle pain, those taking statins without symptoms, and people not taking statins. The goal was to see if acylcarnitine levels could help explain or predict muscle side effects from statins.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help explain why some people get muscle pain from statins and point toward ways to predict or manage this side effect.
- What could go wrong
- This is a small, observational study (38 participants) that only measures biological markers, not a treatment. Results may not apply to all populations or lead to direct clinical changes.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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38 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Oct 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of adult participants (≥18 years) of Caucasian ethnicity recruited at the Latvian Cardiology Center of Pauls Stradiņš Clinical University Hospital. The study includes three groups: (1) patients with elevated creatine kinase levels with or without muscle symptoms suggestive of statin-associated muscle myopathy, (2) patients receiving stable high-dose statin therapy without muscle symptoms, and (3) individuals not receiving lipid-lowering therapy and without unexplained muscle symptoms. Participants may be hospitalized patients or outpatients, including referrals from other medical institutions. All participants must provide written informed consent, and a subset of participants may additionally consent to undergo muscle biopsy for further analysis of mitochondrial metabolism in muscle tissue.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age at least 18 years. 2. A representative of the Caucasian race. 3. The patient agrees to participate in the study by signing an informed consent form for participation in the study. (The patient may only be included in the muscle biopsy sub-study if the relevant additional informed consent form has also been signed.) 4. Specific inclusion criteria for each of the study subgroups: 1. Group A: patients have elevated creatine kinase levels \>1.5x above the upper limit of normal (women \>325 U/L and men \>504 U/L) with or without muscle symptoms that have no other obvious explanation (including intense physical activity in the last 7 days). 2. Group B: atorvastatin 40-80 mg or rosuvastatin 20-40 mg monotherapy for at least 8 weeks at a constant dose and no muscle symptoms (pain, weakness, fatigue, cramps) during this period, CK \<200 U/L. 3. Group C: no lipid-lowering agents have been used during the last year and there have been no muscle symptoms (pain, weakness, fatigue, cramps) of unknown origin lasting \>1 week during this period, CK \<200 U/L. Exclusion Criteria: 1. Any disease that, in the opinion of the investigator, could also cause a significant increase in CK or muscle symptoms. 2. Use of other cholesterol-lowering agents specific to each of the study groups: 1. Group A: use of red yeast rice extract, fibrates, or bempedoic acid within the last 8 weeks. 2. Group B: use of other non-statin cholesterol-lowering agents (red yeast rice extract, ezetimibe, fibrates, PCSK9 inhibitors, inclisiran, bempedoic acid) in the last 8 weeks. 3. Group C: use of any cholesterol-lowering agents (statins, red yeast rice extract, ezetimibe, fibrates, PCSK9 inhibitors, inclisiran, bempedoic acid) in the last 12 weeks. 3. Intense physical activity in the last 7 days. 4. Acute myocardial infarction or stroke in the last 4 weeks. 5. Major surgery within the last 4 weeks (invasive cardiac procedures are not an exclusion criterion). 6. Patients with severe illness that, in the investigator's opinion, may significantly affect the patient's overall metabolism (e.g., active malignancy, terminal heart failure, etc.). 7. Excessive alcohol consumption (binge drinking or \>7 units of alcohol per day) within the last year. 8. Use of other substances or medications known to have direct myotoxic effects (e.g., fibrates, cyclosporins, labetalol, propofol, procainamide, interferon-alpha, hydroxyurea, zidovudine, colchicine, vincristine, amiodarone, corticosteroids) or that may affect CK elevation. 9. Use of meldonium within the last 2 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Latvia (Faculty of Medicine and Institute of Cardiology and Regenerative Medicine)
Riga, Latvia
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