Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04224181
Other study ID # 2019P001220
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT06013813 - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI N/A
Completed NCT04507529 - Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients N/A
Recruiting NCT06066970 - Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Recruiting NCT03620266 - Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI N/A
Completed NCT04097912 - Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
Completed NCT04153006 - Comparison of Fingerstick Versus Venous Sample for Troponin I.
Completed NCT03668587 - Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement
Recruiting NCT01218776 - International Survey of Acute Coronary Syndromes in Transitional Countries
Completed NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Recruiting NCT05371470 - Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation N/A
Recruiting NCT04562272 - Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting NCT06007950 - Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health N/A
Withdrawn NCT05327855 - Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI) Phase 2
Recruiting NCT02876952 - High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients N/A
Completed NCT02711631 - Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation N/A
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02552407 - Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis N/A
Completed NCT02305602 - A Study of VentriGel in Post-MI Patients Phase 1