Inflammation and Cardiovascular Health in Women

  • STATUS
    Recruiting
  • participants needed
    65
  • sponsor
    Massachusetts General Hospital
Updated on 19 February 2024
HIV Infection
antiretroviral agents
ct scan
angiography
SPECT Scan
myocardial infarction
infarct
computed tomography angiography
hiv test

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.

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.

Details
Condition Myocardial Infarction, Ischemic Heart Disease, HIV/AIDS
Age 40-79 years
Treatment Cardiac PET, 99mTc-tilmanocept SPECT/CT, Contrast Enhanced Coronary and Aortic Computed Tomography Angiography
Clinical Study IdentifierNCT04224181
SponsorMassachusetts General Hospital
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

b'WHIV:'
b'female nascent sex'
b'HIV'
b'age 40-79'
b'self-report of stable ART for at least 180 days prior to study entry - any regimen (no'
b'more than 30 days missed medication in the last 180 days)'

Exclusion Criteria

b'self-reported history of MI, stroke, coronary revascularization'
b'stable or unstable angina symptoms'
b'a pre-existing diagnosis of diabetes, being actively treated with oral or injectable'
b'antihyperglycemic medication'
b'current cocaine use'
b'current use of exogenous oral, or transdermal, injected, or depot estrogen or'
b'testosterone'
b'current treatment with prescription, systemic (oral, IV, or IM) steroids, or'
b'anti-inflammatory/immune suppressant medical therapies (excluding topical therapies,'
b'UV therapy, ASA-derivative therapies, or NSAIDs) for autoimmune/inflammatory diseases'
b'(psoriasis, RA, IBD, lupus), post-transplant care, asthma, or pain syndromes'
b'use of oral steroids or prescription oral anti-inflammatory/immune suppressant'
b'medication for >7 days within the past 30 days prior to entry'
b'pregnant or breastfeeding'
b'eGFR < 60 ml/min/1.73 m2 calculated by CKD-EPI12'
b'known severe allergy to iodinated contrast media (CCTA), dextrans/DTPA/radiometals'
b'(99mTc-tilmanocept SPECT/CT), or regadenoson/adenosine (cardiac PET/CT).'
b'self-reported significant radiation exposure (>2 CT angiograms) received within the'
b'past 12 months'
b'concurrent enrollment in conflicting research study.'
b'Non-HIV-infected women:'
b'As above, save for addition of inclusion criteria for negative HIV test and absent'
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