Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
62 participants
OBSERVATIONAL
2020-02-03
2023-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Women with HIV
Individuals with female nascent sex who have been diagnosed with HIV.
Cardiac PET
A scan examining blood flow to the heart
99mTc-tilmanocept SPECT/CT
A scan to look at inflammation in the arteries
Contrast Enhanced Coronary and Aortic Computed Tomography Angiography
A scan of the heart and surrounding blood vessels
Women without HIV
Individuals with female nascent sex who do not have HIV.
Cardiac PET
A scan examining blood flow to the heart
99mTc-tilmanocept SPECT/CT
A scan to look at inflammation in the arteries
Contrast Enhanced Coronary and Aortic Computed Tomography Angiography
A scan of the heart and surrounding blood vessels
Interventions
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Cardiac PET
A scan examining blood flow to the heart
99mTc-tilmanocept SPECT/CT
A scan to look at inflammation in the arteries
Contrast Enhanced Coronary and Aortic Computed Tomography Angiography
A scan of the heart and surrounding blood vessels
Eligibility Criteria
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Inclusion Criteria
* HIV
* age 40-79
* self-report of stable ART for at least 180 days prior to study entry - any regimen (no more than 30 days missed medication in the last 180 days)
Exclusion
* self-reported history of MI, stroke, coronary revascularization
* stable or unstable angina symptoms
* a pre-existing diagnosis of diabetes, being actively treated with oral or injectable antihyperglycemic medication
* current cocaine use
* current use of exogenous oral, or transdermal, injected, or depot estrogen or testosterone
* current treatment with prescription, systemic (oral, IV, or IM) steroids, or anti-inflammatory/immune suppressant medical therapies (excluding topical therapies, UV therapy, ASA-derivative therapies, or NSAIDs) for autoimmune/inflammatory diseases (psoriasis, RA, IBD, lupus), post-transplant care, asthma, or pain syndromes
* use of oral steroids or prescription oral anti-inflammatory/immune suppressant medication for \>7 days within the past 30 days prior to entry
* pregnant or breastfeeding
* eGFR \< 60 ml/min/1.73 m2 calculated by 2021 CKD-EPI Creatinine
* known severe allergy to iodinated contrast media (CCTA), dextrans/DTPA/radiometals (99mTc-tilmanocept SPECT/CT), or regadenoson/adenosine (cardiac PET/CT).
* self-reported significant radiation exposure (\>2 CT angiograms) received within the past 12 months
* concurrent enrollment in conflicting research study.
Non-HIV-infected women:
40 Years
79 Years
FEMALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Markella V. Zanni,M.D.
Associate Professor of Medicine, Harvard Medical School
Principal Investigators
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Markella V. Zanni, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2019P001220
Identifier Type: -
Identifier Source: org_study_id
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