Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma

Ki vehet részt

• Provision to sign and date the consent form
• Stated willingness to comply with all study procedures and be available for the duration of the study
• Be a male aged ≥55 years or a female aged ≥65 years
• For those able to bear children, documentation or report of menopausal status via approximate last menstrual period or hysterectomy due to contraindication of pregnancy for the CCTA procedure. Those without documentation or report of menopausal status require a negative urine pregnancy test (serum pregnancy test will only be done if needed to confirm an ambiguous or positive urine test)
• 5. Have a melanoma diagnosis without prior course(s) of ICI use and planning to start (or currently on) first course of ICI therapy (PD-1, PD-L1, CTLA-4, LAG3). ICI start can occur prior to consent (up to 90 days prior to eligibility CCTA) as long as it is first exposure. ICI therapy can be received as standard of care or other trial treatment for their cancer
• Plaque stage ≥ 1 on screening CCTA

Ki nem vehet részt

• Any prior major cardiovascular event, defined as myocardial infarction, stroke, coronary revascularization, or other major cardiovascular event determined to be significant by the principal investigator
• Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., > 80 beats per minute). EKG must be performed within 1 year prior to signing the consent form or at screening
• Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment
• Contraindication to dosing with beta blocker as needed or nitroglycerin prior to CCTA procedure
• If a patient's CCTA demonstrates previously undiagnosed obstructive coronary disease, they will not be eligible for the study. Obstructive disease will be defined as >50% obstruction in the left main coronary artery, or >70% obstruction elsewhere in the coronary tree
• Allergy to iodinated contrast or history of contrast-induced nephropathy
• Renal insufficiency (eGFR < 45 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation). A current eGFR value (collected/calculated within 3 months prior to signing the consent form or at screening) is required at baseline
• If a patient's fast LDL-C is > 190 mg/dL, this is consistent with underlying familial hypercholesterolemia, and they will not be eligible for the study. A current value must be collected within 90 days prior to signing the consent form or at screening
• Meeting any of the standard CCTA contraindications listed below:
• Hemodynamic instability
• Weight > 400 lbs. (181 kg) or above manufacturer-recommended limit for scanner and table, whichever is lower
• Pregnancy
• Inability to hold breath for > 10 seconds
• Inability to cooperate with scan acquisition and/or breath-hold instructions
• Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA