Recruitment

Recruitment Status
Terminated
Estimated Enrollment
100

Inclusion Criteria

Age 22 and above with prior head and neck or chest irradiation
Pre-existing plaques (detected by ultrasound, CT or MRI)
Asymptomatic major arterial stenosis
...
Age 22 and above with prior head and neck or chest irradiation
Pre-existing plaques (detected by ultrasound, CT or MRI)
Asymptomatic major arterial stenosis
Six months or more post head and neck irradiation
Not being considered for arterial surgery or endovascular treatment.
Documented subclinical cardiovascular disease (inflammatory markers in the serum)

Exclusion Criteria

Recurrence of cancer (with or without treatment)
Presence of stents or external clips that can cause artifacts impairing accurate interpretation of MRI data
Planned surgical or endovascular intervention for revascularization of carotid arteries at the time of enrollment
...
Recurrence of cancer (with or without treatment)
Presence of stents or external clips that can cause artifacts impairing accurate interpretation of MRI data
Planned surgical or endovascular intervention for revascularization of carotid arteries at the time of enrollment
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
Medically unstable or hematologic, renal, or hepatic dysfunction
Estimated glomerular filtration rate (eGFR) < 45 (calculation based on serum creatinine levels, race, age and gender)
Renal failure
Non-atherosclerotic arterial stenosis (dissection)

Summary

Conditions
Atherosclerosis
Type
Interventional
Phase
Phase 4
Design
  • 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)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 22 years and 125 years
Gender
Both males and females

Description

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 ...

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.

Inclusion Criteria

Age 22 and above with prior head and neck or chest irradiation
Pre-existing plaques (detected by ultrasound, CT or MRI)
Asymptomatic major arterial stenosis
...
Age 22 and above with prior head and neck or chest irradiation
Pre-existing plaques (detected by ultrasound, CT or MRI)
Asymptomatic major arterial stenosis
Six months or more post head and neck irradiation
Not being considered for arterial surgery or endovascular treatment.
Documented subclinical cardiovascular disease (inflammatory markers in the serum)

Exclusion Criteria

Recurrence of cancer (with or without treatment)
Presence of stents or external clips that can cause artifacts impairing accurate interpretation of MRI data
Planned surgical or endovascular intervention for revascularization of carotid arteries at the time of enrollment
...
Recurrence of cancer (with or without treatment)
Presence of stents or external clips that can cause artifacts impairing accurate interpretation of MRI data
Planned surgical or endovascular intervention for revascularization of carotid arteries at the time of enrollment
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
Medically unstable or hematologic, renal, or hepatic dysfunction
Estimated glomerular filtration rate (eGFR) < 45 (calculation based on serum creatinine levels, race, age and gender)
Renal failure
Non-atherosclerotic arterial stenosis (dissection)

Tracking Information

NCT #
NCT02114697
Collaborators
Not Provided
Investigators
  • Principal Investigator: John Oshinski, PhD Emory University
  • John Oshinski, PhD Emory University
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