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CXCR2 Leucocyte Expression Level as a Predictive Factor of Coronary Artery Calcification Progression in Advanced Chronic Kidney Disease Patients (MACXCALCIF)

3. september 2026 opdateret af: Centre Hospitalier Universitaire, Amiens
Chronic kidney disease (CKD) is associated with the development of coronary arteries calcifications (CAC) and increased cardiovascular mortality. Previously, the investigators demonstrated that interleukin 8 (IL-8) plays a role in the calcification process, and that blockade of its receptor, CXCR2 reduces cardiovascular calcifications. The investigators hypothesize that leucocytes expressing CXCR2 may contribute to the development and progression of CAC in CKD patients. Identifying CKD patients with a high calcification phenotype and therapeutic targets to prevent cardiovascular calcifications is essential. Advanced CKD patients (stages IV and V) will undergo analysis of CXCR2 expression from neutrophils and monocytes at inclusion by flow cytometry, followed by non-contrast thoracic CT scans at inclusion, 1 year and 3 years to assess calcification scores and progression. Patients will have a pre-inclusion visit for research information and consent. If consent is given, three protocol visits (inclusion, 1 year, 3 years) including clinical exam, laboratory tests and CT evaluations will be performed.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Frankrig
      • Amiens, Frankrig, 80480
        • CHRU Amiens
        • Kontakt:
        • Underforsker:
          • Dimitri TITECA-BEAUPORT, MD
        • Underforsker:
          • Cédric RENARD, MD
        • Underforsker:
          • Thomas BOYER, MD
        • Underforsker:
          • Youssef BENNIS, Pr

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • age > 18 years
  • CKD defined by eGFR < 30 mL/min/1,73m²
  • signed inform consent

Exclusion Criteria:

  • patients on dialysis,
  • kidney transplant recipients,
  • current or recent (within 30 days) infection,
  • inflammatory diseases,
  • active cancer treatment,
  • use of immunosuppressive agents,
  • presence of coronary stents or aortic valve protheses,
  • inability to provide informed consent.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CKD patienter
Andet: Thoracic CT
Thoracic CT will be performed at inclusion, 1 year and 3 years to assess coronary calcification and aortic valve calcification scores and progression.
Biologisk: Blood samples
Blood samples will be collected at inclusion, 1 year and 3 years to measure CXCR1 and CXR2 expression on neutrophils and monocytes by flow cytometry.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
variation from baseline of CXCR2 expression
Tidsramme: at 3 years
CXCR2 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells) from blood sample.
at 3 years
Correlation between CXCR2 expression and calcium score
Tidsramme: at 3 years
The coronary calcification score will be determined by Agatston method. CXCR2 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells) from blood sample.
at 3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CXCR2 expression and the 1-year progression of the calcium score
Tidsramme: at 1 year
The coronary calcification score will be determined by Agatston method. CXCR2 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells) from blood sample.
at 1 year
Correlation between CXCR1 or CXCR2 expression and calcium score trajectory
Tidsramme: 1 year
The coronary calcification score will be determined by Agatston method. CXCR2 expression and CXCR1 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells and percentage of CXCR1 positive cells) from blood sample.
1 year
Correlation between CXCR2 expression and the calcium score progression in other vascular territories
Tidsramme: at 3 years
The coronary calcification score will be determined by Agatston method. CXCR2 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells) from blood sample.
at 3 years
Correlation between CXCR1 expression and the calcium score progression in other vascular territories
Tidsramme: at 3 years
The coronary calcification score will be determined by Agatston method. CXCR1 expression will be quantified by flow cytometry (percentage of CXCR1-positive cells) from blood sample.
at 3 years
Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and CKD progression
Tidsramme: at 3 years
The coronary calcification score will be determined by Agatston method. CXCR2 expression and CXCR1 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells and percentage of CXCR1 positive cells) from blood sample.
at 3 years
Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and the occurrence of cardiovascular complications
Tidsramme: at 3 years
CXCR2 expression and CXCR1 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells and percentage of CXCR1 positive cells) from blood sample.
at 3 years
Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and mortality
Tidsramme: at 3 years
CXCR2 expression and CXCR1 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells and percentage of CXCR1 positive cells) from blood sample.
at 3 years
Correlation between leukocyte phenotype and serum indoxyl sulfate concentration
Tidsramme: at 3 years
at 3 years

Samarbejdspartnere og efterforskere

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

Sponsor

Centre Hospitalier Universitaire, Amiens

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 (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. august 2029

Studieafslutning (Anslået)

1. august 2031

Datoer for studieregistrering

Først indsendt

23. juli 2026

Først indsendt, der opfyldte QC-kriterier

3. september 2026

Først opslået (Faktiske)

10. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PI2026_843_0037

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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