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Clinical Trials/NCT04224181
NCT04224181
Completed
Not Applicable

Inflammation and Cardiovascular Health in Women

Massachusetts General Hospital1 site in 1 country62 target enrollmentFebruary 3, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Massachusetts General Hospital
Enrollment
62
Locations
1
Primary Endpoint
Coronary flow reserve on Cardiac PET
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 3, 2020
End Date
November 9, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Markella V. Zanni,M.D.

Associate Professor of Medicine, Harvard Medical School

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Coronary flow reserve on Cardiac PET

Time Frame: Baseline

Secondary Outcomes

  • 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)

Study Sites (1)

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