Accelerated Atherosclerosis in High Risk Population Groups: An Assessment by Magnetic Resonance Imaging
NCT ID: NCT02114697
Last Updated: 2018-09-11
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE4
Total Enrollment
9 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-04-30
Study Completion Date
2017-07-31
Brief Summary
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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.
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.
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Detailed Description
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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 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.
Conditions
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Atherosclerosis
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Investigators
Study Groups
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Lifestyle modification
Lifestyle modification is tailored to each participant and includes a recommended exercise regimen, a healthy diet and decreasing alcohol intake.
Group Type
ACTIVE_COMPARATOR
Lifestyle modification
Intervention Type
BEHAVIORAL
Lifestyle modification includes a recommended exercise regimen, a healthy diet and decreasing alcohol intake for 3 years.
Statin therapy
Participants will receive statin medication along with instruction about regular exercise.
Group Type
EXPERIMENTAL
Statin therapy
Intervention Type
DRUG
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.
Interventions
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Statin therapy
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.
Intervention Type
DRUG
Lifestyle modification
Lifestyle modification includes a recommended exercise regimen, a healthy diet and decreasing alcohol intake for 3 years.
Intervention Type
BEHAVIORAL
Other Intervention Names
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Crestor
Eligibility Criteria
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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.
* 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
* 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
Minimum Eligible Age
22 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Emory University
OTHER
Sponsor Role
lead
Responsible Party
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John Oshinski
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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John Oshinski, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University
Atlanta, Georgia, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB00059784
Identifier Type: -
Identifier Source: org_study_id
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