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Inflammation and Cardiovascular Health in Women

Inflammation and Cardiovascular Health in Women

Recruiting
40-79 years
Female
Phase N/A

Overview

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.

Eligibility

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 CKD-EPI12
  • 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.

Study details
    Myocardial Infarction
    Ischemic Heart Disease
    HIV/AIDS

NCT04224181

Massachusetts General Hospital

16 February 2024

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