Inflammation and Cardiovascular Health in Women

Completed

• Conditions: HIV/AIDS; Myocardial Infarction
• Interventions: Radiation: Cardiac PET; Radiation: 99mTc-tilmanocept SPECT/CT; Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography Angiography

• 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

Arm && Interventions

Group	Intervention	Description
Women with HIV	Cardiac PET	Individuals with female nascent sex who have been diagnosed with HIV.
Women with HIV	Contrast Enhanced Coronary and Aortic Computed Tomography Angiography	Individuals with female nascent sex who have been diagnosed with HIV.
Women without HIV	Cardiac PET	Individuals with female nascent sex who do not have HIV.
Women with HIV	99mTc-tilmanocept SPECT/CT	Individuals with female nascent sex who have been diagnosed with HIV.
Women without HIV	Contrast Enhanced Coronary and Aortic Computed Tomography Angiography	Individuals with female nascent sex who do not have HIV.
Women without HIV	99mTc-tilmanocept SPECT/CT	Individuals with female nascent sex who do not have HIV.

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