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OpenTrials
Completed

NCT Number: NCT04224181

Inflammation and Cardiovascular Health in Women

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac PET

Radiation

A scan examining blood flow to the heart

99mTc-tilmanocept SPECT/CT

Radiation

A scan to look at inflammation in the arteries

Contrast Enhanced Coronary and Aortic Computed Tomography Angiography

Radiation

A scan of the heart and surrounding blood vessels

Primary outcomes

  1. Coronary flow reserve on Cardiac PET

    Time frame: Baseline

Secondary outcomes

  1. Arterial inflammation on 99mTc-tilmanocept SPECT/CT

    Time frame: Baseline

  2. Atherosclerotic plaque on Contrast Enhanced Coronary and Aortic Computed Tomography Angiography

    Time frame: Baseline

  3. Fractional Flow Reserve

    Time frame: Baseline

  4. Markers of inflammation/immune activation

    Time frame: Baseline

  5. Markers of endothelial dysfunction

    Time frame: Baseline

  6. Markers of mitochondrial disease/dysfunction

    Time frame: Baseline

  7. Markers of myocardial stretch/injury

    Time frame: Baseline

  8. Hormonal/metabolic parameters

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2020
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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