An observational study in HIV, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Massachusetts General Hospital · Observational
The purpose of this study is to measure arterial 99mTc-Tilmanocept uptake using single photon emission computed tomography (SPECT/CT) scanning in HIV infected subjects known to have subclinical coronary atherosclerosis as assessed by contrast-enhanced coronary computed tomography angiography (CCTA).
Detailed Description:
Patients with HIV have been shown to have increased atherosclerotic risk compared to age-matched controls, and this risk is thought to be related to increased systemic immune activation. Specifically, systemic immune activation may contribute to destabilizing coronary atherosclerotic plaque, leading to plaque rupture and myocardial infarction. This study is intended to measure arterial uptake of the macrophage specific marker 99mTc-Tilmanocept using single photon emission computed tomography, applied initially to a group of HIV-infected patients with known subclinical coronary atherosclerosis on CCTA. Moreover, traditional markers of CVD risk and inflammatory markers will be assessed in relation to CV imaging outcomes. Positive findings in the index HIV group with known subclinical atherosclerosis will prompt subsequent study of three comparison groups, as above.
135 studies on the registry are indexed under Arteritis; 26 are open to participants now.
This study's enrollment of 30 is below the median of 114 across 63 observational studies indexed under Arteritis.
Browse Arteritis studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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HIV-infected subjects and HIV non-infected subjects
HIV infected subjects with known subclinical atherosclerosis:
Inclusion criteria:
Exclusion criteria:
HIV infected subjects without known subclinical atherosclerosis:
Inclusion criteria:
Exclusion criteria:
HIV negative subjects with known subclinical atherosclerosis:
Inclusion criteria:
Exclusion criteria:
HIV negative subjects without known subclinical atherosclerosis:
Inclusion criteria:
Exclusion criteria:
Other: Arterial Imaging
Other: Arterial Imaging
Other: Arterial Imaging
Other: Arterial Imaging
Aortic 99mTc-Tilmanocept uptake on SPECT/CT scanning in HIV Patients
Time frame: within 6 weeks of screening visit
Aortic plaque burden and morphology on CCTA in HIV Patients
Time frame: within 6 weeks of screening visit
Traditional markers of cardiovascular disease (CVD) risk and inflammatory markers in relation to cardiovascular imaging outcomes
Time frame: within 6 weeks of screening visit
Imaging assessments in the coronary vasculature in HIV patients
Time frame: within 6 weeks of screening visit
Comparison of imaging assessments b/ HIV patients w/ known subclinical atherosclerosis, HIV patients w/o known subclinical atherosclerosis, non HIV patients w/ known subclinical atherosclerosis and non HIV patients w/o known subclinical atherosclerosis
Time frame: within 6 weeks of screening visit
99mTc-Tilmanocept uptake on SPECT/CT in regions other than the aorta
Time frame: within 6 weeks of screening visit
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital