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
| Type | Name | Description |
|---|---|---|
| RADIATION | Cardiac PET | A scan examining blood flow to the heart |
| RADIATION | 99mTc-tilmanocept SPECT/CT | A scan to look at inflammation in the arteries |
| RADIATION | Contrast Enhanced Coronary and Aortic Computed Tomography Angiography | A 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.