Accelerated Atherosclerosis in High Risk Population Groups: An Assessment by Magnetic Resonance Imaging
| Status: | Terminated |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 9/13/2018 |
| Start Date: | April 2014 |
| End Date: | July 2017 |
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.
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.
Cardiovascular disease (CVD) and cancer are the leading causes of suffering and death amongst
the American population. While an ever-increasing number of cancer survivors have a favorable
outcome due to advances in cancer treatment; cancer survivors remain at high risk of
developing CVD at an early age. There is scant information available on the pathogenic
process that contributes to cardiovascular threat amongst cancer survivors and little is
known about the interventions, which may interrupt or decrease the risk of CVD in this
population. Importantly, early-subclinical markers may substantially precede clinical
markers.
The objective of this project is to accurately determine the constituents and characteristics
of atherosclerotic plaques in carotid arteries by magnetic resonance imaging (MRI) techniques
in cancer survivors; at different data intervals: before and after administration of
treatment (medical and life style modification) and then correlate contrast agent dynamics
with serum markers of inflammation and other tests of cardiac or vascular dysfunction, where
available.
The proposed study involves 100 asymptomatic patients who received prior chest or head and
neck radiation therapy (HNXRT) as part of cancer treatment. MRI data (direct assessment of
atherosclerosis) would be correlated with indirect measures of atherosclerosis (blood
surrogate markers & metabolomics).
The investigators intend to conduct an initial baseline MRI, blood tests (to correlate with
surrogate markers of inflammation) and other tests whenever available of cardiac or vascular
dysfunction. This cohort will be followed up with medication and/or life style modification
regimen for a period of initially18 months and subsequently at 36 months. A repeat of all
baseline studies (MRI and blood tests) would be performed as part of the 18 and 36-month
follow-up. The plaque characteristics found at MRI will be correlated with results of blood
tests (baseline, 18 and 36 months) and changes in one or both will be the expected end point
of the study.
the American population. While an ever-increasing number of cancer survivors have a favorable
outcome due to advances in cancer treatment; cancer survivors remain at high risk of
developing CVD at an early age. There is scant information available on the pathogenic
process that contributes to cardiovascular threat amongst cancer survivors and little is
known about the interventions, which may interrupt or decrease the risk of CVD in this
population. Importantly, early-subclinical markers may substantially precede clinical
markers.
The objective of this project is to accurately determine the constituents and characteristics
of atherosclerotic plaques in carotid arteries by magnetic resonance imaging (MRI) techniques
in cancer survivors; at different data intervals: before and after administration of
treatment (medical and life style modification) and then correlate contrast agent dynamics
with serum markers of inflammation and other tests of cardiac or vascular dysfunction, where
available.
The proposed study involves 100 asymptomatic patients who received prior chest or head and
neck radiation therapy (HNXRT) as part of cancer treatment. MRI data (direct assessment of
atherosclerosis) would be correlated with indirect measures of atherosclerosis (blood
surrogate markers & metabolomics).
The investigators intend to conduct an initial baseline MRI, blood tests (to correlate with
surrogate markers of inflammation) and other tests whenever available of cardiac or vascular
dysfunction. This cohort will be followed up with medication and/or life style modification
regimen for a period of initially18 months and subsequently at 36 months. A repeat of all
baseline studies (MRI and blood tests) would be performed as part of the 18 and 36-month
follow-up. The plaque characteristics found at MRI will be correlated with results of blood
tests (baseline, 18 and 36 months) and changes in one or both will be the expected end point
of the study.
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
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