Clinical Trials Directory

Trials / Completed

CompletedNCT04224181

Inflammation and Cardiovascular Health in Women

Status
Completed
Phase
Study type
Observational
Enrollment
62 (actual)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
Female
Age
40 Years – 79 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATIONCardiac PETA scan examining blood flow to the heart
RADIATION99mTc-tilmanocept SPECT/CTA scan to look at inflammation in the arteries
RADIATIONContrast Enhanced Coronary and Aortic Computed Tomography AngiographyA scan of the heart and surrounding blood vessels

Timeline

Start date
2020-02-03
Primary completion
2023-11-09
Completion
2023-11-09
First posted
2020-01-13
Last updated
2024-02-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04224181. Inclusion in this directory is not an endorsement.