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Use of 99mTc Tilmanocept for Imaging Arterial Inflammation

4. april 2022 opdateret af: Steven K. Grinspoon, MD, Massachusetts General Hospital
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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

HIV-infected subjects and HIV non-infected subjects

Beskrivelse

HIV infected subjects with known subclinical atherosclerosis:

Inclusion criteria:

  • men and women, ages 18+, with documented HIV infection
  • current use of antiretroviral therapy (ART), with no changes to regimen within last 3 months
  • history of subclinical atherosclerosis on CCTA

Exclusion criteria:

  • pregnancy or breastfeeding
  • known active opportunistic infection requiring ongoing medical therapy (not including Hepatitis B/C)
  • CD4 count < 50 cells/mm3
  • history of angina, myocardial infarction, acute coronary syndrome, or coronary artery stenting or surgery
  • recent and/or current treatment with prescription, systemic steroids or anti-inflammatory/immune suppressant medical therapies
  • current use of statin or use of statin for > 1 month within the last 6 months
  • known allergy to dextrans and/or DPTA and/or radiometals and/or iodinated contrast media
  • eGFR < 60 ml/min/1.73 m2 calculated by CDK-EPI
  • contraindications to beta blockers or nitroglycerin
  • significant radiation exposure (>2 CT angiograms) received within the past 12 months
  • BMI > 35 kg/m2 or waist circumference > 70 cm (scanner limitations)

HIV infected subjects without known subclinical atherosclerosis:

Inclusion criteria:

  • men and women, ages 18+, with documented HIV infection
  • current use of antiretroviral therapy (ART), with no changes to regimen within last 3 months
  • history of clean aorta/ coronaries on CCTA

Exclusion criteria:

- Same as exclusion criteria for HIV infected subjects with known subclinical atherosclerosis

HIV negative subjects with known subclinical atherosclerosis:

Inclusion criteria:

  • men and women, ages 18+, without documented HIV infection
  • history of subclinical atherosclerosis on CCTA

Exclusion criteria:

  • pregnancy or breastfeeding
  • history of angina, myocardial infarction, acute coronary syndrome, or coronary artery stenting or surgery
  • recent and/or current treatment with prescription, systemic steroids or anti-inflammatory/immune suppressant medical therapies
  • current use of statin or use of statin for > 1 month within the last 6 months
  • known allergy to dextrans and/or DPTA and/or radiometals and/or iodinated contrast media
  • eGFR < 60 ml/min/1.73 m2 calculated by CDK-EPI
  • contraindications to beta blockers or nitroglycerin
  • significant radiation exposure (>2 CT angiograms) received within the past 12 months
  • BMI > 35 kg/m2 or waist circumference > 70 cm (scanner limitations)

HIV negative subjects without known subclinical atherosclerosis:

Inclusion criteria:

  • men and women, ages 18+, without documented HIV infection
  • history of clean aorta/coronaries on CCTA

Exclusion criteria:

- Same as exclusion criteria for HIV negative subjects with known subclinical atherosclerosis

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Tværsnit

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
HIV infected with known subclinical atherosclerosis
Andet: Arterial Imaging
HIV infected without known subclinical atherosclerosis
Andet: Arterial Imaging
Non-HIV infected with known subclinical atherosclerosis
Andet: Arterial Imaging
Non-HIV infected without known subclinical atherosclerosis
Andet: Arterial Imaging

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Aortic 99mTc-Tilmanocept uptake on SPECT/CT scanning in HIV Patients
Tidsramme: within 6 weeks of screening visit
within 6 weeks of screening visit

Sekundære resultatmål

Resultatmål
Tidsramme
Aortic plaque burden and morphology on CCTA in HIV Patients
Tidsramme: within 6 weeks of screening visit
within 6 weeks of screening visit
Traditional markers of cardiovascular disease (CVD) risk and inflammatory markers in relation to cardiovascular imaging outcomes
Tidsramme: within 6 weeks of screening visit
within 6 weeks of screening visit
Imaging assessments in the coronary vasculature in HIV patients
Tidsramme: within 6 weeks of screening visit
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
Tidsramme: within 6 weeks of screening visit
within 6 weeks of screening visit
99mTc-Tilmanocept uptake on SPECT/CT in regions other than the aorta
Tidsramme: within 6 weeks of screening visit
within 6 weeks of screening visit

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Massachusetts General Hospital

Samarbejdspartnere

Navidea Biopharmaceuticals
Havard University Center for AIDS Research

Efterforskere

  • Ledende efterforsker: Steven Grinspoon, M.D., Massachusetts General Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2015

Primær færdiggørelse (Faktiske)

1. august 2021

Studieafslutning (Faktiske)

1. august 2021

Datoer for studieregistrering

Først indsendt

26. august 2015

Først indsendt, der opfyldte QC-kriterier

4. september 2015

Først opslået (Skøn)

7. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2014P001832

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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Kliniske forsøg med HIV

Kliniske forsøg med Arterial Imaging

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