HIV/AIDSNCT04224181
Inflammation and Cardiovascular Health in Women
An observational study of HIV/AIDS and Myocardial Infarction, run by Massachusetts General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Myocardial Infarction
- What is being tested?
- Cardiac PET, 99mTc-tilmanocept SPECT/CT and Contrast Enhanced Coronary and Aortic Computed Tomography Angiography
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 9 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: - Women with HIV and women without HIV
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the detailed 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.
- Conditions
- HIV/AIDS, Myocardial Infarction
- Being tested
- Cardiac PET, 99mTc-tilmanocept SPECT/CT, Contrast Enhanced Coronary and Aortic Computed Tomography Angiography
- Keywords
- Women, Arterial Inflammation, Systemic Immune Activation, Endothelial Dysfunction, Cardiovascular Disease Risk
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Myocardial Infarction, Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac PETRadiation
A scan examining blood flow to the heart
99mTc-tilmanocept SPECT/CTRadiation
A scan to look at inflammation in the arteries
Contrast Enhanced Coronary and Aortic Computed Tomography AngiographyRadiation
A scan of the heart and surrounding blood vessels
| Study group | Role | What they receive |
|---|---|---|
| Women with HIV | Individuals with female nascent sex who have been diagnosed with HIV. Receives: 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. Receives: Radiation: Cardiac PET; Radiation: 99mTc-tilmanocept SPECT/CT; Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary flow reserve on Cardiac PET
Measured: Baseline
Secondary outcomes (8)
Arterial inflammation on 99mTc-tilmanocept SPECT/CT
Measured: Baseline
Atherosclerotic plaque on Contrast Enhanced Coronary and Aortic Computed Tomography Angiography
Measured: Baseline
Fractional Flow Reserve
Measured: Baseline
Markers of inflammation/immune activation
Measured: Baseline
Markers of endothelial dysfunction
Measured: Baseline
Markers of mitochondrial disease/dysfunction
Measured: Baseline
Markers of myocardial stretch/injury
Measured: Baseline
Hormonal/metabolic parameters
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start3 Feb 2020
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Markella V. Zanni,M.D., Massachusetts General Hospital
- Investigators
- Markella V. Zanni, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224181
- Sponsor's protocol ID
- 2019P001220
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Cardiovascular Health in Women
- ClinicalTrials.gov ID
- NCT04224181
- Acronym / sponsor ID
- 2019P001220
- Conditions
- HIV/AIDS, Myocardial Infarction
- Keywords
- Women, Arterial Inflammation, Systemic Immune Activation, Endothelial Dysfunction, Cardiovascular Disease Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with HIV | – | Radiation: Cardiac PET, Radiation: 99mTc-tilmanocept SPECT/CT, Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography AngiographyIndividuals with female nascent sex who have been diagnosed with HIV. |
| Women without HIV | – | Radiation: Cardiac PET, Radiation: 99mTc-tilmanocept SPECT/CT, Radiation: Contrast Enhanced Coronary and Aortic Computed Tomography AngiographyIndividuals with female nascent sex who do not have HIV. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - Women with HIV and women without HIV
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac PETA scan examining blood flow to the heart | Radiation | Women with HIV, Women without HIV |
| 99mTc-tilmanocept SPECT/CTA scan to look at inflammation in the arteries | Radiation | Women with HIV, Women without HIV |
| Contrast Enhanced Coronary and Aortic Computed Tomography AngiographyA scan of the heart and surrounding blood vessels | Radiation | Women with HIV, Women without HIV |
Primary outcome
Coronary flow reserve on Cardiac PET
Time frame: Baseline
8 secondary outcomes
Arterial inflammation on 99mTc-tilmanocept SPECT/CT
Time frame: Baseline
Atherosclerotic plaque on Contrast Enhanced Coronary and Aortic Computed Tomography Angiography
Time frame: Baseline
Fractional Flow Reserve
Time frame: Baseline
Markers of inflammation/immune activation
Time frame: Baseline
Markers of endothelial dysfunction
Time frame: Baseline
Markers of mitochondrial disease/dysfunction
Time frame: Baseline
Markers of myocardial stretch/injury
Time frame: Baseline
Hormonal/metabolic parameters
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markella V. Zanni, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS and Myocardial Infarction, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary flow reserve on Cardiac PET (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.