Effects of Lomitapide on Carotid and Aortic Atherosclerosis
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Study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide.
Condition or disease
Homozygous Familial Hypercholesterolemia
This is a multi-center long-term open-label non-comparative study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide. Patients from countries in the EU, the US and Canada who are being treated with lomitapide and are enrolled in The Lomitapide Observational Worldwide Evaluation Registry (LOWER), will be invited by the LOWER enrolling physician to participate in this substudy.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients enrolled in LOWER
• Adult patients (age ≥18 years) who are enrolled in LOWER
Patients with a prior history of carotid angioplasty, carotid stenting, or carotid atherectomy
Patients with a contraindication to MRI examination (i.e., brain aneurysm, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body, or other implanted body)
Patients who have undergone a coronary stenting procedure in the preceding three weeks prior to enrollment
Patients prone to claustrophobia or known anxiety disorders that will interfere with the ability to acquire quality MRI scans
Patients with an implanted insulin pump
Patients with metal shrapnel or bullet wounds
Patients with a body mass index (BMI) > 40 kg/m2 (since it may be difficult to position comfortably with the MRI scanner)
Patients who work with metal lathes (unless an orbit x-ray performed prior to the enrollment MRI scan has been done to rule out metal fragments in the eye)