Inflammation and Cardiovascular Health in Women

Mass General Brigham

Status: Completed

Conditions: Myocardial Infarction; HIV/AIDS

Treatments: Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography Angiography; Radiation: Cardiac PET; Radiation: 99mTc-tilmanocept SPECT/CT

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04224181

2019P001220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: Female

Ages: 40 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

62 participants in 2 patient groups

Women with HIV

Description:

Individuals with female nascent sex who have been diagnosed with HIV.

Treatment:

Radiation: 99mTc-tilmanocept SPECT/CT

Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography Angiography

Radiation: Cardiac PET

Women without HIV

Description:

Individuals with female nascent sex who do not have HIV.

Treatment:

Radiation: 99mTc-tilmanocept SPECT/CT

Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography Angiography

Radiation: Cardiac PET