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Inflammation and Cardiovascular Health in Women

Inflammation and Cardiovascular Health in Women

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04224181
Enrollment
62
Registered
2020-01-13
Start date
2020-02-03
Completion date
2023-11-09
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS, Myocardial Infarction

Keywords

Women, Arterial Inflammation, Systemic Immune Activation, Endothelial Dysfunction, Cardiovascular Disease Risk

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.

Interventions

RADIATIONCardiac PET

A scan examining blood flow to the heart

RADIATION99mTc-tilmanocept SPECT/CT

A scan to look at inflammation in the arteries

RADIATIONContrast Enhanced Coronary and Aortic Computed Tomography Angiography

A scan of the heart and surrounding blood vessels

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 79 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
Coronary flow reserve on Cardiac PETBaseline

Secondary

MeasureTime frame
Atherosclerotic plaque on Contrast Enhanced Coronary and Aortic Computed Tomography AngiographyBaseline
Fractional Flow ReserveBaseline
Markers of inflammation/immune activationBaseline
Arterial inflammation on 99mTc-tilmanocept SPECT/CTBaseline
Markers of mitochondrial disease/dysfunctionBaseline
Markers of myocardial stretch/injuryBaseline
Hormonal/metabolic parametersBaseline
Markers of endothelial dysfunctionBaseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026