TerminatedPhase 4

Accelerated Atherosclerosis in High Risk Population Groups: An Assessment by Magnetic Resonance Imaging

Stopped: The study was stopped when the original principal investigator moved to a new institution.

United States9 participantsStarted 2014-04

Plain-language 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.

Who can participate

Age range22 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Plaque Volume of Carotid Arteries

Timeframe: Baseline, 18 months, 36 months

Trial details

NCT IDNCT02114697

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07

Results submitted2018-07-17