Inflammation and Cardiovascular Health in Women

Completed

• Conditions: HIV/AIDS; Myocardial Infarction

• Registration Number: NCT04224181
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2020-02-03
• Primary Completion: 2023-11-09
• Study Completion: 2023-11-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-17
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary flow reserve on Cardiac PET	Baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States