HIV/AIDS, Myocardial Infarction
Conditions
Keywords
Women, Arterial Inflammation, Systemic Immune Activation, Endothelial Dysfunction, Cardiovascular Disease Risk
Brief summary
Systemic immune activation and inflammation are believed to play a significant role in the development and clinical course of myocardial infarction (MI). Among women with HIV (WHIV), heightened systemic immune activation and inflammation persist, even when HIV infection is well-treated with contemporary antiretroviral therapeutic regimens. Moreover, WHIV in high-resource regions face a three-fold increased risk of myocardial infarction as compared with matched non-HIV-infected women. The goals of this study are to better understand ways in which HIV infection-incited systemic immune activation and inflammation augment MI risk among women.
Detailed description
The goals of this study are to better understand ways in which HIV infection-incited systemic immune activation and inflammation augment MI risk among women. To this end, WHIV and non-HIV-infected women will undergo structural and functional cardiovascular imaging studies (Cardiac PET, 99mTc-tilmanocept SPECT/CT, Contrast Enhanced Coronary and Aortic Computed Tomography Angiography) as well as vascular, metabolic/hormonal, and immune phenotyping. Measures of immune activation, arterial inflammation, and cardiovascular pathology will be compared between groups and interrelationships between these parameters will be assessed among WHIV.
Interventions
A scan examining blood flow to the heart
A scan to look at inflammation in the arteries
A scan of the heart and surrounding blood vessels
Sponsors
Study design
Eligibility
Inclusion criteria
WHIV: Inclusion * female nascent sex * 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: As above, save for addition of inclusion criteria for negative HIV test and absent inclusion criteria for HIV and self-report of stable ART.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coronary flow reserve on Cardiac PET | Baseline |
Secondary
| Measure | Time frame |
|---|---|
| Atherosclerotic plaque on Contrast Enhanced Coronary and Aortic Computed Tomography Angiography | Baseline |
| Fractional Flow Reserve | Baseline |
| Markers of inflammation/immune activation | Baseline |
| Arterial inflammation on 99mTc-tilmanocept SPECT/CT | Baseline |
| Markers of mitochondrial disease/dysfunction | Baseline |
| Markers of myocardial stretch/injury | Baseline |
| Hormonal/metabolic parameters | Baseline |
| Markers of endothelial dysfunction | Baseline |
Countries
United States