Inflammation and Cardiovascular Health in Women

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04224181

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

40.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS Myocardial Infarction	Radiation: Cardiac PET Radiation: 99mTc-tilmanocept SPECT/CT Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography Angiography

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Inflammation and Cardiovascular Health in Women

Actual Study Start Date :

Feb 3, 2020

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Women with HIV Individuals with female nascent sex who have been diagnosed with HIV.	Radiation: Cardiac PET A scan examining blood flow to the heart Radiation: 99mTc-tilmanocept SPECT/CT A scan to look at inflammation in the arteries Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography Angiography A scan of the heart and surrounding blood vessels
Women without HIV Individuals with female nascent sex who do not have HIV.	Radiation: Cardiac PET A scan examining blood flow to the heart Radiation: 99mTc-tilmanocept SPECT/CT A scan to look at inflammation in the arteries Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography Angiography A scan of the heart and surrounding blood vessels

Arm

Intervention/Treatment

Women with HIV

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

Radiation: Cardiac PET

A scan examining blood flow to the heart

Radiation: 99mTc-tilmanocept SPECT/CT

A scan to look at inflammation in the arteries

Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography Angiography

A scan of the heart and surrounding blood vessels

Women without HIV

Individuals with female nascent sex who do not have HIV.

Radiation: Cardiac PET

A scan examining blood flow to the heart

Radiation: 99mTc-tilmanocept SPECT/CT

A scan to look at inflammation in the arteries

Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography Angiography

A scan of the heart and surrounding blood vessels

Outcome Measures

Primary Outcome Measures

Coronary flow reserve on Cardiac PET [Baseline]

Secondary Outcome Measures

Arterial inflammation on 99mTc-tilmanocept SPECT/CT [Baseline]
Atherosclerotic plaque on Contrast Enhanced Coronary and Aortic Computed Tomography Angiography [Baseline]
Fractional Flow Reserve [Baseline]
Markers of inflammation/immune activation [Baseline]
Markers of endothelial dysfunction [Baseline]
Markers of mitochondrial disease/dysfunction [Baseline]
Markers of myocardial stretch/injury [Baseline]
Hormonal/metabolic parameters [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 79 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.