Inflammation and Cardiovascular Health in Women

Myocardial Infarction Clinical Trial

Official title:

Inflammation and Cardiovascular Health in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224181
• Other study ID #: 2019P001220
• Status: Completed
• Start date: February 3, 2020
• Est. completion date: November 9, 2023

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 9, 2023
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV/AIDS
• Infarction
• Inflammation
• Myocardial Infarction

Intervention

Radiation:
• Cardiac PET
A scan examining blood flow to the heart
• 99mTc-tilmanocept SPECT/CT
A scan to look at inflammation in the arteries
• Contrast Enhanced Coronary and Aortic Computed Tomography Angiography
A scan of the heart and surrounding blood vessels

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary flow reserve on Cardiac PET		Baseline
Secondary	Arterial inflammation on 99mTc-tilmanocept SPECT/CT		Baseline
Secondary	Atherosclerotic plaque on Contrast Enhanced Coronary and Aortic Computed Tomography Angiography		Baseline
Secondary	Fractional Flow Reserve		Baseline
Secondary	Markers of inflammation/immune activation		Baseline
Secondary	Markers of endothelial dysfunction		Baseline
Secondary	Markers of mitochondrial disease/dysfunction		Baseline
Secondary	Markers of myocardial stretch/injury		Baseline
Secondary	Hormonal/metabolic parameters		Baseline