NCT04224181Completed
Inflammation and Cardiovascular Health in Women
Source: ClinicalTrials.gov · Last updated 20 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 62 (actual)
- First submitted
- 8 Jan 2020
- Start date
- 3 Feb 2020
- Primary completion date
- 9 Nov 2023
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Coronary artery disease, HIV
- NCT number
- NCT04224181
What you commit to
- Study type: Observational
- Participants enrolled: 62
- From 3 Feb 2020 to the primary completion date, 9 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- WHIV:
- Inclusion
- female nascent sex
- HIV
- age 40-79
- self-report of stable ART for at least 180 days prior to study entry - any regimen (no more than 30 days missed medication in the last 180 days)
- Exclusion
- self-reported history of MI, stroke, coronary revascularization
- stable or unstable angina symptoms
- a pre-existing diagnosis of diabetes, being actively treated with oral or injectable antihyperglycemic medication
- current cocaine use
- current use of exogenous oral, or transdermal, injected, or depot estrogen or testosterone
- current treatment with prescription, systemic (oral, IV, or IM) steroids, or anti-inflammatory/immune suppressant medical therapies (excluding topical therapies, UV therapy, ASA-derivative therapies, or NSAIDs) for autoimmune/inflammatory diseases (psoriasis, RA, IBD, lupus), post-transplant care, asthma, or pain syndromes
- use of oral steroids or prescription oral anti-inflammatory/immune suppressant medication for \>7 days within the past 30 days prior to entry
- pregnant or breastfeeding
- eGFR \< 60 ml/min/1.73 m2 calculated by 2021 CKD-EPI Creatinine
- known severe allergy to iodinated contrast media (CCTA), dextrans/DTPA/radiometals (99mTc-tilmanocept SPECT/CT), or regadenoson/adenosine (cardiac PET/CT).
- self-reported significant radiation exposure (\>2 CT angiograms) received within the past 12 months
- concurrent enrollment in conflicting research study.
- Non-HIV-infected women:
- As above, save for addition of inclusion criteria for negative HIV test and absent inclusion criteria for HIV and self-report of stable ART.
Age in the registry: 40 years to 79 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.