7 Tesla MRI study in patients with statin related muscle complaints

Study ID
STU 012016-017

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Advanced Imaging Research Center (AIRC)
  • CTRC Outpatient

Contact
Chandna Vasandani
214/648-5074
CHANDNA.VASANDANI@UTSouthwestern.edu

Principal Investigator
Zahid Ahmad, M.D.

Summary

We plan to do 2 substudies.
The goal of the first study will be to generate hypothesis regarding the long-term effects of statin in muscles by studying 7T MRS findings in patients who are currently experiencing statin-related muscle complaints or who have a history of severe reactions to statins (i.e. rhabdomyolysis, anti-HMGCR-associated autoimmune myopathy, or CK elevation [Greater Than] 10 times the upper limit of normal). We anticipate enrolling roughly 5 such patients. The protocol involves a single visit for a blood draw and MRS of calf muscle. The data will be compared to historical controls provided by the advanced imaging Research Center.
Second, we will study the effect of short-term statin administration in 5 patients with a history of statin related muscle complaints and 5 controls with no statin related muscle complaints . Controls will be matched for age, weight, and body mass index. Patients will undergo a wash-out of lipid lowering drugs followed by a challenge with simvastatin 40 mg daily (similar to a statin withdrawal and rechallenge). We chose simvastatin since it is the most common statin that caused myopathy according to our preliminary data (as well as most other published reports). each patient will have 5 visits. The screening visit will involve a review of inclusion/exclusion criteria, blood draw, questionnaire, and instructions to withhold all lipid lowering drugs until visit 1. any patient with known antibodies to HMGCR will be excluded from the remainder of the study.
Visit 1 will occur 2 weeks after stopping all lipid lowering drugs. a minimum 2 week period off lipid lowering drugs is required to allow clearance of any medication from the systemic circulation. Patients will undergo MRS of the calf muscle and a blood draw. Patients will then start simvastatin 40 mg daily.
Visit 2 will occur 1 week after starting simvastatin and will get MRS and blood draw.
Visit 3 will occur 2 weeks after starting simvastatin and will get MRS and blood draw.
Visit 4 will occur 4 weeks after starting simvastatin and will get MRS and blood draw.

Participant Eligibility

Inclusion criteria for substudy 1 include:

1.)Adults, age 18 years or older
2.)One of the following:
a.Patients who are currently taking a statin and experiencing muscle pain, aches, weakness, cramps, stiffness, or
* heaviness
* in the legs. Since the MRI/MRS studies will be limited to calves, patient will have to have leg symptoms to qualify, or
b.Patients with HMGCR antibodies, or
c.Patients with a history of statin-induced CK elevation of > 10 times the upper limit of normal, or
d.Patients with a history of statin-induced rhabdomyolysis
3.)Subjects should be willing to participate under the conditions described in the informed consent form (ICF) and must be able to sign the ICF and applicable HIPAA forms.
4.)Ability to exercise without physical restrictions.

Inclusion criteria for substudy 2 include:

1.)Adults, age 18 years or older
2.)Patients who report complaints of statin-related muscle pain, aches, weakness, cramps, stiffness, or
* heaviness
* in the legs. Since the MRI/MRS studies will be limited to calves, patient will have to have leg symptoms to qualify.
3.)Subjects should be willing to participate under the conditions described in the informed consent form (ICF) and must be able to sign the ICF and applicable HIPAA forms.
4.)Ability to exercise without physical restrictions.