Inflammation and Cardiovascular Health in Women

NCT04224181 | Completed

• 1 other identifier: 2019P001220
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; Myocardial Infarction

Keywords

Women; Arterial Inflammation; Systemic Immune Activation; Endothelial Dysfunction; Cardiovascular Disease Risk

Outcome Measures

Primary Outcomes (1)

• Coronary flow reserve on Cardiac PET

  Baseline

Secondary Outcomes (8)

• Arterial inflammation on 99mTc-tilmanocept SPECT/CT

  Baseline

• Atherosclerotic plaque on Contrast Enhanced Coronary and Aortic Computed Tomography Angiography

  Baseline

• Fractional Flow Reserve

  Baseline

• Markers of inflammation/immune activation

  Baseline

• Markers of endothelial dysfunction

  Baseline

Study Arms (2)

Women with HIV

Individuals with female nascent sex who have been diagnosed with HIV.

Radiation: Cardiac PET; Radiation: 99mTc-tilmanocept SPECT/CT; Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography Angiography

Women without HIV

Individuals with female nascent sex who do not have HIV.

Radiation: Cardiac PET; Radiation: 99mTc-tilmanocept SPECT/CT; Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography Angiography

Interventions

Cardiac PET RADIATION

A scan examining blood flow to the heart

Women with HIV; Women without HIV

99mTc-tilmanocept SPECT/CT RADIATION

A scan to look at inflammation in the arteries

Women with HIV; Women without HIV

Contrast Enhanced Coronary and Aortic Computed Tomography Angiography RADIATION

A scan of the heart and surrounding blood vessels

Women with HIV; Women without HIV

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

\- Women with HIV and women without HIV

You may qualify if:

• 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)

You may not qualify if:

• 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:

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, PBMCs, plasma, serum, endothelial cells

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Myocardial Infarction; Arteritis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Vasculitis

Study Officials

• Markella V. Zanni, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: February 3, 2020
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

US (1)