Clinical trial NCT04224181: Inflammation and Cardiovascular Health in Women
Official title: Inflammation and Cardiovascular Health in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Myocardial Infarction
Keywords: Women
Arterial Inflammation
Systemic Immune Activation
Endothelial Dysfunction
Cardiovascular Disease Risk
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-01-13
Enrollment: 62
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: - Women with HIV and women without HIV

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.

Eligibility 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.

Primary outcomes:
measure: Coronary flow reserve on Cardiac PET
timeFrame: Baseline
Secondary outcomes:
measure: Arterial inflammation on 99mTc-tilmanocept SPECT/CT
timeFrame: Baseline
measure: Atherosclerotic plaque on Contrast Enhanced Coronary and Aortic Computed Tomography Angiography
timeFrame: Baseline
measure: Fractional Flow Reserve
timeFrame: Baseline
measure: Markers of inflammation/immune activation
timeFrame: Baseline
measure: Markers of endothelial dysfunction
timeFrame: Baseline
measure: Markers of mitochondrial disease/dysfunction
timeFrame: Baseline
measure: Markers of myocardial stretch/injury
timeFrame: Baseline
measure: Hormonal/metabolic parameters
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Markella V. Zanni, MD
role: PRINCIPAL_INVESTIGATOR
References: