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Human Atherosclerotic Plaque Inflammation Imaged Using PDG-PET/CT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kevin Yarasheski, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00958815
First received: August 12, 2009
Last updated: June 22, 2012
Last verified: June 2012

August 12, 2009
June 22, 2012
March 2009
March 2010   (final data collection date for primary outcome measure)
Standard uptake values (SUV) for 18Fluoro-deoxyglucose in the carotid vessels and aorta of HIV-infected people with cardiovascular disease risk factors and compared to the same in HIV-seronegative people with no cardiovascular disease risk factors. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00958815 on ClinicalTrials.gov Archive Site
Carotid intima media thickness measures will be compared to carotid 18FDG SUV. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Same as current
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Human Atherosclerotic Plaque Inflammation Imaged Using PDG-PET/CT
Human Atherosclerotic Plaque Inflammation Imaged Using PDG-PET/CT

People with diabetes are at increased risk for atherosclerosis and have high CVD morbidity and mortality rates. Tools for detecting and quantifying atherosclerotic pro/regression in people with diabetes and other CVD risk factors lack sensitivity and specificity for molecular level events that occur during the early stages of atherogenesis. Inflammatory macrophage infiltration in the vessel endothelium is an early, molecular level proatherogenic event. Activated macrophages consume glucose at a high rate. Novel in vivo radiotracer PET/CT techniques have been developed to detect, image and quantify molecular level events like macrophage inflammation and glucose utilization (18FDG) in human vessels. We propose to develop and test this novel technique in the Center for Clinical Imaging Research (CCIR) at WUMS. We propose that HIV-infected people with significant CVD risk profiles are a suitable, unique human model for testing these novel imaging techniques. HIV-infected people taking anti-HIV medications develop insulin resistance, T2DM, dyslipidemia, central adiposity, and hypertension. HIV replicates in macrophages and represents a chronic proinflammatory condition. Recent data indicate that HIV+ CVD risk have greater risk for atherosclerosis and MI than HIV-negative people. To test feasibility, we hypothesize that: a.18FDG-PET/CT imaging will detect more macrophage glucose uptake and inflammation in the carotid and aorta arteries of HIV-infected people with CVD risk than in HIV-negative controls; b. radiotracer PET/CT measures of proatherogenic processes will correlate with carotid intima media thickness; a standard measure of carotid atherosclerotic burden. We propose to obtain pilot data that shows feasibility for a novel analytical approach that will expand capabilities for researchers interested in studying the links between diabetes, inflammation, and CVD in humans.

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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

Subjects will be recruited through the AIDS Clinical Trials Unit (ACTU), Washington University Infectious Diseases Clinics, primary care physicians in the community who refer patients to these clinics and Volunteers for Health (VFH).

  • Insulin Resistance
  • Atherosclerosis
  • Cardiovascular Disease
  • HIV/AIDS
  • HIV Infections
Not Provided
  • HIV-seronegative with no CVD risk factors
    Healthy, 35-60 yr old HIV-seronegative men and women with no CVD risk factors (normal fasting glucose tolerance, normal fasting lipid/lipoprotein levels, normotensive, waist circumference <102cm (men) and <88cm (women).
  • HIV+ with CVD risk factors
    35-60 yr old HIV-infected men and women with insulin resistance, dyslipidemia, hypertension, and central adiposity.
Yarasheski KE, Laciny E, Overton ET, Reeds DN, Harrod M, Baldwin S, Davila-Roman V. 18FDG PET-CT imaging detects arterial inflammation and early atherosclerosis in HIV-infected adults with cardiovascular disease risk factors. Journal of Inflammation 2012, 9:26 doi:10.1186/1476-9255-9-26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria for HIV+ group:

  • confirmed HIV+ status
  • 35-60 years old
  • stable ART for at least the past 4 mos
  • CD4 count >200 cells/µL
  • HIV RNA <40copies/mL
  • fasting glucose=100-126 mg/dL
  • 2hr-oGTT glucose=140-200mg/dL
  • fasting triglycerides >150mg/dL
  • HDL-cholesterol <40mg/dL (men), <50mg/dL (women)
  • resting blood pressure>130/85mmHg
  • waist circumference >102cm(men), >88cm(women)
  • BMI 25-35 kg/m2

For HIV-negative control group:

  • Confirmed HIV negative status
  • 35-60 years old
  • fasting glucose<100mg/dL,
  • 2hr-oGTT glucose<140mg/dL
  • fasting triglycerides<150mg/dL
  • HDL-cholesterol >40mg/dL (men), >50mg/dL(women)
  • normal BP (<130/85mmHg)
  • no central adiposity (waist circ.<102cm(men), <88cm(women)
  • BMI (25-35 kg/m2)

Exclusion Criteria for both groups:

  • history of heart disease, MI, stroke, transient ischemic attack, kidney or liver disease (active hepatitis B or C), dementia
  • statins, fibrates, TZDs, antihypertensives, low dose aspirin, or other prescribed/over-the-counter agents with anti-inflammatory properties
  • cocaine and methamphetamine users
  • serum creatinine >1.5 mg/dL
  • pregnant women
  • cognitive impairment that limits ability to provide voluntary informed consent
Both
35 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00958815
18FDG (completed), DK-020579
No
Kevin Yarasheski, Washington University School of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Kevin E Yarasheski, PhD Washington University School of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP