Human Atherosclerotic Plaque Inflammation Imaged Using PDG-PET/CT
2 other identifiers
observational
14
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 12, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJune 26, 2012
June 1, 2012
1 year
August 12, 2009
June 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline
Secondary Outcomes (1)
Carotid intima media thickness measures will be compared to carotid 18FDG SUV.
Baseline
Study Arms (2)
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.
Eligibility Criteria
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).
You may qualify if:
- confirmed HIV+ status
- 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
- hr-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
- years old
- +7 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
Yarasheski KE, Laciny E, Overton ET, Reeds DN, Harrod M, Baldwin S, Davila-Roman VG. 18FDG PET-CT imaging detects arterial inflammation and early atherosclerosis in HIV-infected adults with cardiovascular disease risk factors. J Inflamm (Lond). 2012 Jun 22;9(1):26. doi: 10.1186/1476-9255-9-26.
PMID: 22726233RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin E Yarasheski, PhD
Washington University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Cell Biology & Physiology, Physical Therapy
Study Record Dates
First Submitted
August 12, 2009
First Posted
August 13, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
June 26, 2012
Record last verified: 2012-06