Accelerated Atherosclerosis in High Risk Population Groups: An Assessment by Magnetic Resonance Imaging
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Intervention: Statin therapy; Lifestyle modification
Intervention description: Statin therapy includes rosuvastatin 20 mg administered orally, once a day, for the duration of the trial, which is 3 years. Participants may also receive a different type of statin as prescribed by their cardiologist based on clinical judgement.; Lifestyle modification includes a recommended exercise regimen, a healthy diet and decreasing alcohol intake for 3 years.
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The protocol originally specified randomizing participants to a study arm, but the protocol was amended to clarify that a participant's cardiologist could change the treatment regimens that participants were assigned to so that no participant was restricted from statin therapy.
Masking: Single (Investigator)
Enrollment: 9.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No
Keywords: Cancer survivorship; Cardiovascular disease; Stroke; Transient ischemic attack (TIA)

Summary:

      The goal of this study is to assess a slimy substance that settles/deposits along blood
      vessel wall. This slimy substance is called plaque. Plaque could be made up of fat, calcium
      or both. Plaque deposition narrows the vessels. This leads to decreased blood flow to various
      parts of body. Blood vessels include vessels that supply to heart (coronary), vessels to
      brain (carotid), vessels to kidneys (renal) and vessels to legs (femoral). Decreased blood
      flow causes symptoms such as brain stroke, heart attack, leg pain. Similarly individuals at
      risk of cardiovascular disease can have certain markers elevated in their blood that can be
      measured by simple blood tests.

      High or increased plaque deposition is seen in neck vessels of cancer patients who received
      radiation to chest or head and neck as part of their cancer treatment. Cancer survivors are
      at increased risk of plaque development and are therefore called high-risk population.
      Exercise +/- fat lowering medicine can potentially decrease plaque deposition and statins are
      one of the several fat lowering medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 22 and above with prior head and neck or chest irradiation

          -  Six months or more post head and neck irradiation

          -  Documented subclinical cardiovascular disease (inflammatory markers in the serum)

          -  Pre-existing plaques (detected by ultrasound, CT or MRI)

          -  Asymptomatic major arterial stenosis

          -  Not being considered for arterial surgery or endovascular treatment.

        Exclusion Criteria:

          -  Recurrence of cancer (with or without treatment)

          -  Planned surgical or endovascular intervention for revascularization of carotid
             arteries at the time of enrollment

          -  Renal failure

          -  Estimated glomerular filtration rate (eGFR) < 45 (calculation based on serum
             creatinine levels, race, age and gender)

          -  Medically unstable or hematologic, renal, or hepatic dysfunction

          -  Non-atherosclerotic arterial stenosis (dissection)

          -  Presence of stents or external clips that can cause artifacts impairing accurate
             interpretation of MRI data

          -  Contraindications to MRI: cardiac pacemaker, metal implants, metal in eyes, pregnant
             or nursing women, claustrophobia, allergy to MRI contrast

          -  Physical or mental impairment that would limit the patient's ability to comply with
             the medical instructions or study procedures