Inflammation and Cardiovascular Health in Women

STATUS

Recruiting
participants needed

65
sponsor

Massachusetts General Hospital

Send

Updated on 19 February 2024

See if I qualify

HIV Infection

antiretroviral agents

ct scan

angiography

SPECT Scan

myocardial infarction

infarct

computed tomography angiography

hiv test

Summary

Show definitions

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.

Details

Condition	Myocardial Infarction, Ischemic Heart Disease, HIV/AIDS
Age	40years - 79years
Treatment	Cardiac PET, 99mTc-tilmanocept SPECT/CT, Contrast Enhanced Coronary and Aortic Computed Tomography Angiography
Clinical Study Identifier	NCT04224181
Sponsor	Massachusetts General Hospital
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	b'WHIV:'
	b'female nascent sex'
	b'HIV'
	b'age 40-79'
	b'self-report of stable ART for at least 180 days prior to study entry - any regimen (no'
	b'more than 30 days missed medication in the last 180 days)'
Exclusion Criteria
	b'self-reported history of MI, stroke, coronary revascularization'
	b'stable or unstable angina symptoms'
	b'a pre-existing diagnosis of diabetes, being actively treated with oral or injectable'
	b'antihyperglycemic medication'
	b'current cocaine use'
	b'current use of exogenous oral, or transdermal, injected, or depot estrogen or'
	b'testosterone'
	b'current treatment with prescription, systemic (oral, IV, or IM) steroids, or'
	b'anti-inflammatory/immune suppressant medical therapies (excluding topical therapies,'
	b'UV therapy, ASA-derivative therapies, or NSAIDs) for autoimmune/inflammatory diseases'
	b'(psoriasis, RA, IBD, lupus), post-transplant care, asthma, or pain syndromes'
	b'use of oral steroids or prescription oral anti-inflammatory/immune suppressant'
	b'medication for >7 days within the past 30 days prior to entry'
	b'pregnant or breastfeeding'
	b'eGFR < 60 ml/min/1.73 m2 calculated by CKD-EPI12'
	b'known severe allergy to iodinated contrast media (CCTA), dextrans/DTPA/radiometals'
	b'(99mTc-tilmanocept SPECT/CT), or regadenoson/adenosine (cardiac PET/CT).'
	b'self-reported significant radiation exposure (>2 CT angiograms) received within the'
	b'past 12 months'
	b'concurrent enrollment in conflicting research study.'
	b'Non-HIV-infected women:'
	b'As above, save for addition of inclusion criteria for negative HIV test and absent'

How to participate?

Step 1 Connect with a study center

Send a message

Enter your contact details to connect with study team

First name*

Last name*

Email*

Phone number*

Other language

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

HIV Infection

antiretroviral agents

ct scan

angiography

SPECT Scan

myocardial infarction

infarct

computed tomography angiography

hiv test

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Inflammation and Cardiovascular Health in Women